125742 S1 M5 CRF c4591001 1007 10071192

Document text

Page 1 of 283
***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: 10071192 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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130982
Page 2 of 283
***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: 10071192 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/13/2020
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130983
Page 3 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10071192]
2.Birth Date: /1943
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0130984
Page 4 of 283
***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: 10071192 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/13/2020
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130985
Page 5 of 283
***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: 10071192 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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130986
Page 6 of 283
***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: 10071192 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/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130987
Page 7 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: Dec/UNK/1992
Ongoing: NO
End Date:
Dec/UNK/1992
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine fibroid polyp]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
Dec/UNK/1992
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bladder prolapse]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130988
Page 8 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cystocele repair]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: Feb/UNK/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 diabetes mellitus]
Start Date: Mar/UNK/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Basal cell carcinoma of skin in situ]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130989
Page 9 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Plastic repair of pinna]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Basal cell carcinoma]
Start Date: UNK/UNK/2010
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left ventricular hypertrophy]
Start Date: Feb/27/2019
Ongoing: YES
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130990
Page 10 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bursitis of right hip]
Start Date: UNK/UNK/2019
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Barrett's esophagus]
Start Date: Mar/17/2017
Ongoing: NO
End Date:
Aug/9/2019
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic gastritis]
Start Date: Mar/17/2017
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic kidney disease stage 3]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130991
Page 11 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [64.3]
3.Unit: kg
4.Height: [154.0]
5.Unit: cm
6.Body Mass Index: [27.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130992
Page 12 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130993
Page 13 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [228139]
3.Randomization Group: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130994
Page 14 of 283
***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: 10071192 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/13/2020
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 [BM817Y]
5.bSample ID [BM817Z]
5.cSample ID [BM8180]
5.dSample ID [BPG06D]
5.eSample ID [BPG06F]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130995
Page 15 of 283
***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: 10071192 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/13/2020
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 [BM816F]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130996
Page 16 of 283
***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: 10071192 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/13/2020 14:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130997
Page 17 of 283
***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: 10071192 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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130998
Page 18 of 283
***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: 10071192 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/3/2020
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0130999
Page 19 of 283
***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: 10071192 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
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131000
Page 20 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131001
Page 21 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131002
Page 22 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131003
Page 23 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131004
Page 24 of 283
***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: 10071192 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:
Sep/3/2020
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 [BP75NY]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131005
Page 25 of 283
***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: 10071192 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: Sep/3/2020 14:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131006
Page 26 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131007
Page 27 of 283
***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: 10071192 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
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131008
Page 28 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131009
Page 29 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131010
Page 30 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BPYTW1]
5.bSample ID [BMPSGY]
5.cSample ID [BMPSGZ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131011
Page 31 of 283
***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: 10071192 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:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131012
Page 32 of 283
***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: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131013
Page 33 of 283
***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: 10071192 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 [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131014
Page 34 of 283
***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: 10071192 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 [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131015
Page 35 of 283
***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: 10071192 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?
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131016
Page 36 of 283
***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: 10071192 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:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131017
Page 37 of 283
***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: 10071192 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:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131018
Page 38 of 283
***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: 10071192 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 [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131019
Page 39 of 283
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131020
Page 40 of 283
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131021
Page 41 of 283
***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: 10071192 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 :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131022
Page 42 of 283
***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: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131023
Page 43 of 283
***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: 10071192 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:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131024
Page 44 of 283
***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: 10071192 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 [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131025
Page 45 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Gastrointestinal Ble
ed Dec/9/2020 U
NK:UNK NO
End Date Time:
Jan/7/2021 UNK:U
NK
 Repeating
Pages
 2.ADVERSE
EVENT 2  right gluteus mediu
s tendon tear Sep/27/2020 U
NK:UNK NO
End Date Time:
Dec/3/2020 UNK:U
NK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Gastric ulcer  Dec/11/2020 U
NK:UNK YES  Repeating
Pages
 4.ADVERSE
EVENT 4  Duodenal ulcer  Dec/17/2020 U
NK:UNK NO
End Date Time:
Feb/11/2021 UNK:
UNK
 Repeating
Pages
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131026
Page 46 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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)[Gastrointestinal Bleed]
4.Start Date Time: Dec/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/7/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131027
Page 47 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[GI bleed after surgery. Gastric and duodenal ulcers.]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131028
Page 48 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
12.Was a Non-Drug Treatment
given?YES
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[2020491752]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131029
Page 49 of 283
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[right gluteus medius tendon tear]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/3/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131030
Page 50 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[injury]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
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[ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131031
Page 51 of 283
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Gastric ulcer]
4.Start Date Time: Dec/11/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131032
Page 52 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[surgical stress]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131033
Page 53 of 283
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Duodenal ulcer]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).NO
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131034
Page 54 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[surgical stress]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131035
Page 55 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131036
Page 56 of 283
***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: 10071192 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[ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131037
Page 57 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131038
Page 58 of 283
***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: 10071192 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: //
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131039
Page 59 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defi
ned Identifie
rCategory fo
r Medicatio
nConcomitant Medi
cations Pre-specifie
dName of
Medicatio
nDose De
scriptionForm Instan
ce
 1. DELETED [ ]      [ ]  [ ]  Repeating
Pages
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131040
Page 60 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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?
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131041
Page 61 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131042
Page 62 of 283
***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: 10071192 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?
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131043
FDA-CBER-2021-5683-0131044
Page 64 of 283
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: PACKED RBC
2.Date of Transfusion: Dec/10/2020
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131045
Page 65 of 283
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: PACKED RBC
2.Date of Transfusion: Dec/16/2020
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131046
Page 66 of 283
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: PACKED RBC
2.Date of Transfusion: Dec/18/2020
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131047
Page 67 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131048
Page 68 of 283
***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: 10071192 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:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131049
Page 69 of 283
***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: 10071192 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:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131050
Page 70 of 283
***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: 10071192 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?
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131051
Page 71 of 283
***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: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131052
Page 72 of 283
***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: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131053
Page 73 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131054
Page 74 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131055
Page 75 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131056
Page 76 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131057
Page 77 of 283
***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: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131058
Page 78 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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/25/2021
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131059
Page 79 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131060
Page 80 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131061
Page 81 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131062
Page 82 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131063
Page 83 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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/25/2021
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 [BRB5L6]
5.bSample ID [BSB7C8]
5.cSample ID [BSB7CB]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131064
Page 84 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRB5L7]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131065
Page 85 of 283
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 11:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131066
Page 86 of 283
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131067
Page 87 of 283
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10071192 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.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131068
Page 88 of 283
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10071192 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 [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131069
Page 89 of 283
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10071192 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?
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131070
Page 90 of 283
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131071
Page 91 of 283
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131072
Page 92 of 283
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131073
Page 93 of 283
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131074
Page 94 of 283
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131075
Page 95 of 283
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 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: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131076
Page 96 of 283
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131077
Page 97 of 283
***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: 10071192 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 Oct/1/2020
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131078
Page 98 of 283
***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: 10071192 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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131079
Page 99 of 283
***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: 10071192 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 21:25:20 (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.
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131080
Page 100 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-13-2020 15:15:10 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131081
Page 101 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormAug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131082
Page 102 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Aug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131083
Page 103 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Aug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131084
Page 104 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Aug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131085
Page 105 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Aug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131086
Page 106 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Aug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131087
Page 107 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131088
Page 108 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131089
Page 109 of 283
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aAug-13-2020 15:15:49 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131090
Page 110 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormSep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131091
Page 111 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Sep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131092
Page 112 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Sep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131093
Page 113 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Sep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131094
Page 114 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Sep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131095
Page 115 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Sep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131096
Page 116 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aSep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131097
Page 117 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aSep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131098
Page 118 of 283
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aSep-03-2020 15:04:50 (UTC-05:00)
Eastern Time (US & Canada)Laura Pace
(pfe.lpace)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131099
Page 119 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-25-2021 11:19:07 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131100
Page 120 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormFeb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131101
Page 121 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
1Feb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131102
Page 122 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
2Feb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131103
Page 123 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
3Feb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131104
Page 124 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
4Feb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131105
Page 125 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
5Feb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131106
Page 126 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131107
Page 127 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131108
Page 128 of 283
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1007 Site Name: (1007) Cincinnati Children's Hospital Medical
Center
Subject No: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6.aFeb-25-2021 11:51:43 (UTC-05:00)
Eastern Time (US & Canada)Haley Muth
(pfe.hmuth)Not Applicable
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131109
Page 129 of 283
***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: 10071192 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 21:25:20 (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 16:29:40 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Feb-07-2021 22:45:44 (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.
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131110
Page 130 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Laura Pace  N/A Jan-30-2021 16:50:49 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Jan-29-2021 22:47:12 (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 Jan-24-2021 19:49:03 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Jan-11-2021 16:00:28 (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.
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131111
Page 131 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Laura Pace  N/A Jan-07-2021 14:08:59 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Dec-30-2020 22:35:20 (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 Dec-22-2020 22:45:56 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Dec-20-2020 22:55:11 (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.
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131112
Page 132 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Laura Pace  N/A Dec-15-2020 20:27:39 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Oct-02-2020 09:29:00 (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 Oct-01-2020 13:32:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Frenck Approved Sep-10-2020 17:20:59 (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.
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131113
Page 133 of 283
***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: 10071192 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-13-2020
15:14:00
(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-13-2020
15:14:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131114
Page 134 of 283
***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: 10071192 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-13-2020
15:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
OBTAINED
Date Written Consent Obt
ained
Aug/13/2020Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131115
Page 135 of 283
***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: 10071192 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-13-2020
15:13:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10071192Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020
15:13:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020
15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020
15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH O
RIGINInitial Entry
5. Race: (Check X all that apply):
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
(b) (6)
FDA-CBER-2021-5683-0131116
Page 136 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-13-2020
15:14:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
WHITEInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131117
Page 137 of 283
***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: 10071192 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-13-2020
15:15:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/13/2020Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131118
Page 138 of 283
***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: 10071192 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-13-2020
15:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020
15:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020
15:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
COMPLETEDInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131119
Page 139 of 283
***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: 10071192 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-13-2020
18:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Hysterectom
y
Start Date: Dec/UNK/1
992
Ongoing: NO
End Date:
Dec/UN
K/1992Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020
18:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-21-2021
20:18:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131120
Page 140 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-21-2021
07:06:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered correct; 'right
gluteus medius
tendon tear start
is 27Sep2020
Jan-21-2021
00:41:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissued:Open
edClinical SAE
med history (in
narrative) has
'right gluteus
medius tendon
tear from
27Sep2020
(right hip open
gluteus medius
repair on
03Dec2020), for
condition &
surgery
immediately
prior to GI bleed
Jan-20-2021
08:00:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Query 1: Answered please clarify
where it is
reported
27feb2020; our
records have
27sep2020
Jan-07-2021
09:06:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL Past
Med Hx does not
contain
condition "right
gluteus medius
tendon tear" on
27Feb20, as
reported in SAE,
which led to
surgical repair
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131121
Page 141 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
on 03Dec20.
Please review for
safety relevance,
and update Med
Hx as
appropriate.
Aug-13-2020
18:54:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
HysterectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020
18:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/UNK/1992Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020
18:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Dec/UNK/1992Initial Entry
1.b
Date Location User Value Reason
Aug-14-2020
12:24:33
(UTC-05:00) EasternACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Line/MH N
umber:2updated medical
history
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131122
Page 142 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) Medical His
tory Term:Uterine fibro
id polyp
Start Date: UNK/UNK/
1992
Ongoing: NO
End Date:
Dec/UN
K/1992
Aug-13-2020
18:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Line/M
H Num
ber:2
Medical
History
Term:Abnormal uterin
e bleeding due to
uterine fibroid
Start D
ate:UNK/UNK/1992
Ongoin
g:NO
End Date:
Dec/UNK/19
92Transcription
Error
Aug-13-2020
18:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:2
Medical
History
Term:Abnormal uterin
e bleeding due to
uterine fibroid
Start D
ate:Dec/UNK/1992Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131123
Page 143 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Ongoin
g:NO
End Date:
Dec/UNK/19
92
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131124
Page 144 of 283
***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: 10071192 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-13-2020
18:55:19
(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 ValueReason
Aug-14-2020
14:00:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query
1: Clo
sedDiscrepancy
has been
closed.
Aug-14-2020
12:24:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dupdated
medical
history
Aug-14-2020
12:24:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data
Entry
:
Uterin
e fibr
oid po
lypupdated
medical
history
Aug-13-2020
22:34:37
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query
1: Op
enedMultiple
concepts in
the term
ABNORMAL
UTERINE
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131125
Page 145 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Canada) BLEEDING
DUE TO
UTERINE
FIBROID.
Split the term
into
ABNORMAL
UTERINE
BLEEDING
and
UTERINE
FIBROID and
submit
separately.
Thank you.
Aug-13-2020
18:55:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data
Entry
:
Abnor
mal ut
erine
bleedi
ng du
e to ut
erine
fibroi
dInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020
18:55:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/1992Transcription
Error
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131126
Page 146 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
18:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Dec/UNK/1992Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020
18:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Dec/UNK/1992Initial Entry
1.c
Date Location User Value Reason
Aug-13-2020
18:56:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Bladder prol
apse
Start Date: UNK/UNK/
2006
Ongoing: NO
End Date:
UNK/UN
K/2006Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131127
Page 147 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020
18:56:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
18:56:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Bladder prolapseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020
18:56:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2006Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020
18:56:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.d
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131128
Page 148 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
18:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Cystocele re
pair
Start Date: UNK/UNK/
2006
Ongoing: NO
End Date:
UNK/UN
K/2006Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131129
Page 149 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020
18:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
18:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Cystocele repairInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020
18:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2006Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020
18:56:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.e
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131130
Page 150 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
18:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Hypothyro
idism
Start Date: Feb/UNK/
2020
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131131
Page 151 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020
18:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
18:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
HypothyroidismInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020
18:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Feb/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020
18:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131132
Page 152 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
18:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Type 2 diabet
es mellitus
Start Date: Mar/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131133
Page 153 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020
18:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
18:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Type 2 diabetes mellitusInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020
18:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Mar/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020
18:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131134
Page 154 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
18:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:Basal cell carcin
oma of skin in si
tu
Start Dat
e:Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/20
19Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131135
Page 155 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020
18:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
18:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Basal cell carcinoma of skin
in situInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020
18:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020
18:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Oct/UNK/2019Initial Entry
1.h
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131136
Page 156 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
19:00:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Plastic repair
of pinna
Start Date: Oct/UNK/20
19
Ongoing: NO
End Date:
Oct/UNK/
2019Initial Entry
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020
19:00:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
19:00:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Plastic repair of pinnaInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131137
Page 157 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.h Start Date:
Date Location User Value Reason
Aug-13-2020
19:00:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/UNK/2019Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020
19:00:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Oct/UNK/2019Initial Entry
1.i
Date Location User Value Reason
Aug-13-2020
19:01:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Basal cell c
arcinoma
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131138
Page 158 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.i Line/MH Number:
Date Location User Value Reason
Aug-13-2020
19:01:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
19:01:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Basal cell carcinomaInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-13-2020
19:01:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-13-2020
19:01:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131139
Page 159 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
19:01:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:Hypercholes
terolemia
Start Date: UNK/UNK/
2005
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131140
Page 160 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.j Line/MH Number:
Date Location User Value Reason
Aug-13-2020
19:01:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
19:01:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
HypercholesterolemiaInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-13-2020
19:01:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2005Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-13-2020
19:01:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131141
Page 161 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Aug-13-2020
19:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:Left ventricul
ar hypertroph
y
Start Date: Feb/27/2019
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131142
Page 162 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.k Line/MH Number:
Date Location User Value Reason
Aug-13-2020
19:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
19:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Left ventricular hypertrophyInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-13-2020
19:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Feb/27/2019Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-13-2020
19:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131143
Page 163 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Jan-07-2021
14:09:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Line/MH Nu
mber:12
Medical Hist
ory Term:Bursitis of
right hip
Start Date: UNK/UNK
/2019
Ongoing: YESTranscription
Error
Jan-07-2021
14:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:Bursitis of
hip
Start Date: UNK/UN
K/2019
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131144
Page 164 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.l Line/MH Number:
Date Location User Value Reason
Jan-07-2021 14:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-07-2021
14:09:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Bursitis of right hipTranscription
Error
Jan-07-2021
14:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Bursitis of hipInitial Entry
1.l Start Date:
Date Location User Value Reason
Jan-07-2021 14:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2019Initial Entry
1.l Ongoing:
Date Location User Value Reason
Jan-07-2021 14:08:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
1.m
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131145
Page 165 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Jan-07-2021 14:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:Barrett's eso
phagus
Start Date: Mar/17/201
7
Ongoing: NO
End Date:
Aug/9/20
19Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131146
Page 166 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.m Line/MH Number:
Date Location User Value Reason
Jan-07-2021 14:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-07-2021 14:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Barrett's esophagusInitial Entry
1.m Start Date:
Date Location User Value Reason
Jan-07-2021 14:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Mar/17/2017Initial Entry
1.m Ongoing:
Date Location User Value Reason
Jan-07-2021 14:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NO
End Date:
Aug/9/2019Initial Entry
1.n
Date Location User Value Reason
Jan-07-2021 14:10:26
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num 14Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131147
Page 167 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) ber:
Medical Histor
y Term:Chronic ga
stritis
Start Date: Mar/17/20
17
Ongoing: YES
1.n Line/MH Number:
Date Location User Value Reason
Jan-07-2021 14:10:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-07-2021 14:10:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Chronic gastritisInitial Entry
1.n Start Date:
Date Location User Value Reason
Jan-07-2021 14:10:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Mar/17/2017Initial Entry
1.n Ongoing:
Date Location User Value Reason
Jan-07-2021 14:10:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131148
Page 168 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.o
Date Location User Value Reason
Jan-07-2021 14:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical Hi
story Term
:Chronic kidne
y disease stage
3
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131149
Page 169 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.o Line/MH Number:
Date Location User Value Reason
Jan-07-2021 14:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-07-2021 14:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Chronic kidney disease stag
e 3Initial Entry
1.o Start Date:
Date Location User Value Reason
Jan-07-2021 14:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
UNK/UNK/2019Initial Entry
1.o Ongoing:
Date Location User Value Reason
Jan-07-2021 14:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131150
Page 170 of 283
***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: 10071192 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-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
64.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
154.0Initial Entry
5. Unit:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131151
Page 171 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-13-2020
15:17:13
(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-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.1Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Record Identif
ier::1
Temperature: 36.5
Temperature
Unit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
7.a Temperature:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131152
Page 172 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-13-2020
15:17:13
(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
Aug-13-2020
15:17:13
(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-13-2020
15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131153
Page 173 of 283
***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: 10071192 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-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131154
Page 174 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Define
d Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131155
Page 175 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Result:
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-13-2020
15:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131156
Page 176 of 283
***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: 10071192 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-13-2020
15:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020
15:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
228139Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131157
Page 177 of 283
***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: 10071192 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-13-2020
15:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
15:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020
16:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
15:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-13-2020 ACV0PFEINFP6000  Laura Pace Data Entry: Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131158
Page 178 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
15:15:33
(UTC-05:00) Eastern
Time (US & Canada)(pfe.lpace) YES
Date of Collection:
Aug/13/2020
5.a
Date Location User Value Reason
Aug-13-2020
16:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM817YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
16:57:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BM817YInitial Entry
5.b
Date Location User Value Reason
Aug-13-2020
16:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM817ZInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131159
Page 179 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.b Sample ID
Date Location User Value Reason
Aug-13-2020
16:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BM817ZInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020
16:57:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM8180Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020
16:57:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BM8180Initial Entry
5.d
Date Location User Value Reason
Aug-13-2020
16:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG06DInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131160
Page 180 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sample ID
Date Location User Value Reason
Aug-13-2020
16:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPG06DInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020
16:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BPG06FInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020
16:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BPG06FInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131161
Page 181 of 283
***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: 10071192 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-13-2020
15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
15:15:39
(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-13-2020
16:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-13-2020 ACV0PFEINFP6000  Laura Pace Data Entry: Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131162
Page 182 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
15:15:39
(UTC-05:00) Eastern
Time (US & Canada)(pfe.lpace) YES
Date of Collection:
Aug/13/2020
5.a
Date Location User Value Reason
Aug-13-2020
16:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BM816FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
16:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BM816FInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131163
Page 183 of 283
***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: 10071192 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-13-2020
17:35:39
(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-13-2020
17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020
17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020
17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Aug/13/2020 14:49Initial Entry
5. Anatomical Location:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131164
Page 184 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Aug-13-2020
17:35:39
(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-13-2020
17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020
17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020
17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Aug-13-2020
17:35:39ACV0PFEINFP6000  Laura
PaceData Entry:
YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131165
Page 185 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)(pfe.lpace)
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131166
Page 186 of 283
***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: 10071192 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-13-2020
17:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131167
Page 187 of 283
***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: 10071192 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-03-2020
15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/3/2020Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131168
Page 188 of 283
***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: 10071192 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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131169
Page 189 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131170
Page 190 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.c
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020
15:06:38ACV0PFEINFP6000  Laura
PaceData Entry:
Symptom:: CInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131171
Page 191 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)(pfe.lpace) HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MI
TIN
GInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131172
Page 192 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NO
2.e Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131173
Page 193 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131174
Page 194 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.g Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED M
USCLE 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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131175
Page 195 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED JOI
NT 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-03-2020
15:06:38
(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-03-2020 15:06:38
(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
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131176
Page 196 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reacti
on::SW
ELL
INGInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131177
Page 197 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
15:06:38
(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-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TEInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131178
Page 198 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were injection site
reactions present
on the last day the
Subject Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
15:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131179
Page 199 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020
15:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/3/2020Initial Entry
2.a
Date Location User Value Reason
Sep-03-2020
15:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Record Identif
ier::1
Temperature: 36.8
Temperature
Unit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-03-2020
15:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-03-2020
15:04:42ACV0PFEINFP6000  Laura
PaceData Entry:
36.8Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131180
Page 200 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)(pfe.lpace)
2.a Unit:
Date Location User Value Reason
Sep-03-2020
15:04:42
(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
Sep-03-2020
15:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131181
Page 201 of 283
***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: 10071192 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
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131182
Page 202 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sponsor-Define
d Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131183
Page 203 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
6.a Result:
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-03-2020
15:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Not ApplicableInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131184
Page 204 of 283
***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: 10071192 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-03-2020 15:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 15:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
15:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
15:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-03-2020
15:01:26
(UTC-05:00) EasternACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131185
Page 205 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
Sep/3/2020
5.a
Date Location User Value Reason
Sep-03-2020
15:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID: BP75NYInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
15:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
BP75NYInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131186
Page 206 of 283
***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: 10071192 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
Sep-03-2020
15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020
15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Sep/3/2020 14:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131187
Page 207 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-03-2020 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020
15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-03-2020
15:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
YESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131188
Page 208 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020 13:32:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Oct/1/2020Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131189
Page 209 of 283
***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: 10071192 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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FE
V
E
R
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26 ACV0PFEINFP6000  Laura Data Entry: Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131190
Page 210 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-05:00) Eastern
Time (US & Canada)Pace
(pfe.lpace)NO
2.b
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131191
Page 211 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: C
HI
LL
SInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131192
Page 212 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:N
O
2.d Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131193
Page 213 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.e Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131194
Page 214 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.f Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131195
Page 215 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.g Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131196
Page 216 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.h Symptom:
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reactio
n::RE
DN
ESInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131197
Page 217 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131198
Page 218 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 13:34:26
(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
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
Injection Site Rea
ction::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present
on the last day the
Subject Diary was
completed?:NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131199
Page 219 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 13:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Laura
Pace
(pfe.lpace)Data Entry:
NOInitial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131200
Page 220 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 13:33:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 13:33:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
15:08:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
13:33:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-01-2020
13:33:19
(UTC-05:00) EasternACV0PFEINFP6000  Laura Pace
(pfe.lpace)Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae4020\Final\Final On: 01-Apr-2021 05:31 (GMT)
FDA-CBER-2021-5683-0131201
Page 221 of 283
***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: 10071192 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
Oct/1/2020
5.a
Date Location User Value Reason
Oct-01-2020
15:08:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jesse
LePage
(pfe.jlepage)Data Entry:
Sample ID:
…[truncated]