125742 S1 M5 CRF c4591001 1156 11561001

Document text

Page 1 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839810
Page 2 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839811
Page 3 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561001]
2.Birth Date: /1958
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839812
Page 4 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839813
Page 5 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.aDescription of Inclusion Criterion
Not MetMale or female participants between the ages of 18 and 55 years, inclusive, 65 and
85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent
upon study phase)
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839814
Page 6 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839815
Page 7 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Shoulder Surgery]
Start Date: Dec/25/1979
Ongoing: NO
End Date:
Dec/25/1979
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Hip Surgery]
Start Date: Aug/UNK/2016
Ongoing: NO
End Date:
Aug/UNK/2016
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Shoulder Surgery]
Start Date: Oct/UNK/2017
Ongoing: NO
End Date:
Oct/UNK/2017
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/1965
Ongoing: YES
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839816
Page 8 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Brazil Nut Allergy]
Start Date: UNK/UNK/1964
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Shoulder Surgery]
Start Date: Oct/UNK/2000
Ongoing: NO
End Date:
Oct/UNK/2000
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dislocated Right Shoulder]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
Oct/UNK/2000
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dislocated Left Shoulder]
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
Dec/25/1979
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839817
Page 9 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Hip Osteoarthritis]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
Aug/UNK/2016
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Correct Failed Right Shoulder Surgery]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Oct/UNK/2017
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839818
Page 10 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [133.3]
3.Unit: LB
4.Height: [65.98]
5.Unit: in
6.Body Mass Index: [21.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839819
Page 11 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [234053]
3.Randomization Group: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839820
Page 12 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BP183W]
5.bSample ID [BP183X]
5.cSample ID [BP183Y]
5.dSample ID [BPHRX0]
5.eSample ID [BPHRX1]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839821
Page 13 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BP183Z]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839822
Page 14 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/19/2020 16:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839823
Page 15 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839824
Page 16 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839825
Page 17 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839826
Page 18 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BP18HJ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839827
Page 19 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/8/2020 14:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839828
Page 20 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839829
Page 21 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BR2Z39]
5.bSample ID [BPHRS5]
5.cSample ID [BPHRS6]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839830
Page 22 of 192
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839831
Page 23 of 192
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/4/2021
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 [BRLYFJ]
5.bSample ID [BS9FWX]
5.cSample ID [BS9FWW]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839832
Page 24 of 192
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839833
Page 25 of 192
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839834
Page 26 of 192
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839835
Page 27 of 192
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839836
Page 28 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839837
Page 29 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839838
Page 30 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839839
Page 31 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839840
Page 32 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839841
Page 33 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839842
Page 34 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839843
Page 35 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839844
Page 36 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839845
Page 37 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839846
Page 38 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839847
Page 39 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839848
Page 40 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839849
Page 41 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839850
Page 42 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  SORE THROAT  Aug/23/2020
UNK:UNK NO
End Date Time:
Aug/30/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  SUBARACHNOID HEMORRHAGE  Oct/6/2020 08
:20 NO
End Date Time:
Oct/17/2020 UNK
:UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  PARTIAL TEAR OF THE RIGHT TRA
PEZIUS MUSCLE (GRADE 1) Oct/6/2020 U
NK:UNK NO
End Date Time:
Mar/4/2021 UNK:
UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  WIDENINNG OFACROMIOCLAVICU
LAR JOINT SPACE (GRADE 1) Oct/6/2020 U
NK:UNK NO
End Date Time:
Mar/4/2021 UNK:
UNK
 Repeating
Pages
 5.ADVERSE
EVENT 5  FRACTURE OF ROOF OF RIGHT OR
BITAL (GRADE 3) Oct/6/2020 U
NK:UNK NO
End Date Time:
Dec/14/2020 UNK
:UNK
 Repeating
Pages
 6.ADVERSE
EVENT 6  TRAUMATIC INTRACRANIAL HEM
ORRHAGE Oct/6/2020 U
NK:UNK NO
End Date Time:
Mar/4/2021 UNK:
UNK
 Repeating
Pages
 7.ADVERSE
EVENT 7  FALL FROM BICYCLE  Oct/6/2020 08
:20 NO
End Date Time:
Oct/6/2020 08:20Repeating
Pages
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839851
Page 43 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839852
Page 44 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[SORE THROAT]
4.Start Date Time: Aug/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/30/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[UNRELATED NEW MEDICAL CONDITION]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839853
Page 45 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839854
Page 46 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[SUBARACHNOID HEMORRHAGE]
4.Start Date Time: Oct/6/2020 08:20
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/17/2020 UNK:UNK
6.Toxicity Grade: 4
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?
YES
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
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839855
Page 47 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[FALL FROM BICYCLE]
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[2020391390]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839856
Page 48 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[PARTIAL TEAR OF THE RIGHT TRAPEZIUS MUSCLE (GRADE 1)]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/4/2021 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
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:
[BICYCLE ACCIDENT]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839857
Page 49 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839858
Page 50 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[WIDENINNG OFACROMIOCLAVICULAR JOINT SPACE (GRADE 1)]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/4/2021 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
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:
[BICYCLE ACCIDENT]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839859
Page 51 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839860
Page 52 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[FRACTURE OF ROOF OF RIGHT ORBITAL (GRADE 3)]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/14/2020 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839861
Page 53 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[BICYCLE ACCIDENT]
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[2020391390]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839862
Page 54 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[TRAUMATIC INTRACRANIAL HEMORRHAGE]
4.Start Date Time: Oct/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/4/2021 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839863
Page 55 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[BICYCLE ACCIDENT]
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[2020391390]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839864
Page 56 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[FALL FROM BICYCLE]
4.Start Date Time: Oct/6/2020 08:20
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/6/2020 08:20
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
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:
[NO UNDERLYING CAUSE]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839865
Page 57 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839866
Page 58 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839867
Page 59 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839868
Page 60 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of MedicationStart D
ateForm Instanc
e
 1.1  VACCINATION
S NO  TETANUS-DIPHTHERI
A VACCINE Oct/6/2
020 Repeating
Pages
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839869
Page 61 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[TETANUS-DIPHTHERIA VACCINE]
5.Date: Oct/6/2020
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839870
Page 62 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839871
Page 63 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839872
Page 64 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839873
Page 65 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839874
Page 66 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839875
Page 67 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839876
Page 68 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839877
Page 69 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839878
Page 70 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839879
Page 71 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839880
Page 72 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839881
Page 73 of 192
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839882
Page 74 of 192
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839883
Page 75 of 192
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839884
Page 76 of 192
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839885
Page 77 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839886
Page 78 of 192
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839887
Page 79 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839888
Page 80 of 192
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839889
Page 81 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839890
Page 82 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839891
Page 83 of 192
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839892
Page 84 of 192
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Mar-08-2021 14:42:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839893
Page 85 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-20-2020 09:23:06 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839894
Page 86 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Hector
Rodriguez Approved Mar-08-2021 14:42:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector Aguilar  N/A Mar-04-2021 17:02:08 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Mar-02-2021 14:06:48 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector Aguilar  N/A Feb-25-2021 14:46:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839895
Page 87 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Hector
Rodriguez Approved Feb-19-2021 12:11:31 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector Aguilar  N/A Feb-18-2021 16:43:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Dec-21-2020 14:34:36 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
Hector Aguilar  N/A Dec-16-2020 15:45:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-04-2020 13:16:40 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0839896
Page 88 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, HectorRodriguez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-04-2020 11:46:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-03-2020 14:15:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HectorRodriguez, 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.
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839897
Page 89 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-19-2020 18:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020 18:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839898
Page 90 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 18:47:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839899
Page 91 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-12-2020 20:46:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-12-2020 15:18:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered UPDATED WITH THE
MINIMAL
INFORMATION
CURRENTLY
AVAILABLE
Oct-09-2020 07:36:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020391390
Head trauma(onset
date:06Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-19-2020
18:45:47 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11561001Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 18:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1958Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 18:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
MALEInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839900
Page 92 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020 18:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 18:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
WHITEInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839901
Page 93 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020 18:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/19/2020Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839902
Page 94 of 192
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 09:22:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Crit
erio
n D
escr
iptio
n:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65 a
nd 85 years, inclusive, or 1
8 and 85 years, inclusive, a
t randomization (dependen
t upon study phase)Transcription Error
(DELETED)
Aug-20-2020 09:19:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Crit
erio
n D
escr
iptio
n:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65 a
nd 85 years, inclusive, or 1
8 and 85 years, inclusive, a
t randomization (dependen
t upon study phase)Initial Entry
1.a Description of Inclusion Criterion Not Met
Date Location User Value Reason
Aug-20-2020 09:22:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Male or female participants betw
een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study phase)Transcription Error
(DELETED)
Aug-20-2020 09:19:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Male or female participants betw
een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study phase)Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839903
Page 95 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-19-2020 18:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 18:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 18:53:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839904
Page 96 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020 18:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Left Shoulder Su
rgery
Start Date: Dec/25/1979
Ongoing: NO
End Date:
Dec/25/1979Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Left Shoulder SurgeryInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-19-2020 18:54:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/25/1979Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020 18:54:37
(UTC-05:00) EasternACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839905
Page 97 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) End Date:
Dec/25/1979
1.b
Date Location User Value Reason
Aug-19-2020 18:55:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Right Hip Surg
ery
Start Date: Aug/UNK/201
6
Ongoing: NO
End Date:
Aug/UNK/2
016Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839906
Page 98 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:55:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 18:55:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Right Hip SurgeryInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-19-2020 18:55:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-19-2020 18:55:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Aug/UNK/2016Initial Entry
1.c
Date Location User Value Reason
Aug-19-2020 18:56:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Right Shoulder S
urgery
Start Date: Oct/UNK/2017Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839907
Page 99 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Date:
Oct/UNK/201
7
1.c Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:56:14
(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-19-2020 18:56:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Right Shoulder SurgeryInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-19-2020 18:56:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-19-2020 18:56:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Oct/UNK/2017Initial Entry
1.d
Date Location User Value Reason
Aug-19-2020 18:57:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839908
Page 100 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical History T
erm:Penicillin Alle
rgy
Start Date: UNK/UNK/1
965
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:57:01
(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-19-2020 18:57:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Penicillin AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-19-2020 18:57:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/1965Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-19-2020 18:57:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-19-2020 18:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Brazil Nut All
ergyInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839909
Page 101 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: UNK/UNK/19
64
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:57:37
(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-19-2020 18:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Brazil Nut AllergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-19-2020 18:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/1964Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-19-2020 18:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-19-2020 18:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Right Shoulder S
urgery
Start Date: Oct/UNK/2000Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839910
Page 102 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Date:
Oct/UNK/200
0
1.f Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:58:20
(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-19-2020 18:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Right Shoulder SurgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-19-2020 18:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-19-2020 18:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Oct/UNK/2000Initial Entry
1.g
Date Location User Value Reason
Aug-19-2020 18:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839911
Page 103 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical Histor
y Term:Dislocated Right
Shoulder
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
Oct/UNK/2000
1.g Line/MH Number:
Date Location User Value Reason
Aug-19-2020 18:59:29
(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-19-2020 18:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dislocated Right ShoulderInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-19-2020 18:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/1996Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-19-2020 18:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Oct/UNK/2000Initial Entry
1.h
Date Location User Value Reason
Aug-19-2020 19:00:22
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num 8Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839912
Page 104 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) ber:
Medical Histor
y Term:Dislocated Left S
houlder
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
Dec/25/1979
1.h Line/MH Number:
Date Location User Value Reason
Aug-19-2020 19:00:22
(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-19-2020 19:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dislocated Left ShoulderInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-19-2020 19:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/1978Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-19-2020 19:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Dec/25/1979Initial Entry
1.i
Date Location User Value Reason
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839913
Page 105 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-19-2020 19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical Histor
y Term:Right Hip Osteoa
rthritis
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
Aug/UNK/20
16Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-19-2020 19:01:19
(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-19-2020 19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Right Hip OsteoarthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-19-2020 19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2008Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-19-2020 19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Aug/UNK/2016Initial Entry
1.j
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839914
Page 106 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-19-2020 19:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Correct Failed Right
Shoulder Surgery
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Oct/UNK/2017Initial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-19-2020 19:02:15
(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-19-2020 19:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Correct Failed Right Shoulder Sur
geryInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-19-2020 19:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-19-2020 19:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Oct/UNK/2017Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839915
Page 107 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
133.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
65.98Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.5Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839916
Page 108 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 19:04:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839917
Page 109 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 19:04:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 19:04:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
234053Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839918
Page 110 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 19:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 19:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020 19:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 19:05:06
(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-19-2020 19:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 19:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP183WInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839919
Page 111 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 19:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP183WInitial Entry
5.b
Date Location User Value Reason
Aug-19-2020 19:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP183XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020 19:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP183XInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020 19:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP183YInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-19-2020 19:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP183YInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020 19:05:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHRX0Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839920
Page 112 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Aug-19-2020 19:05:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRX0Initial Entry
5.e
Date Location User Value Reason
Aug-19-2020 19:06:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHRX1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-19-2020 19:06:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRX1Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839921
Page 113 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 19:06:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 19:06:27
(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-19-2020 19:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-19-2020 19:06:27
(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-19-2020 19:06:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020 19:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP183ZInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839922
Page 114 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-19-2020 19:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP183ZInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839923
Page 115 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-19-2020 19:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 19:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 19:07:27
(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-19-2020 19:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/19/2020 16:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 19:07:27
(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-19-2020 19:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839924
Page 116 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Aug-19-2020 19:07:27
(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-19-2020 19:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-19-2020 19:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839925
Page 117 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020 10:07:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTTranscription Error
Aug-19-2020 19:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839926
Page 118 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 18:41:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/8/2020Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839927
Page 119 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 18:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 18:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 18:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 18:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 18:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839928
Page 120 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-08-2020 18:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839929
Page 121 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 18:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 18:42:54
(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-08-2020 18:43:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 18:42:54
(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-08-2020 18:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 18:43:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP18HJInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839930
Page 122 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 18:43:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18HJInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839931
Page 123 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 18:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 18:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 18:42:13
(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-08-2020 18:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/8/2020 14:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 18:42:13
(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-08-2020 18:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839932
Page 124 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Sep-08-2020 18:42:13
(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-08-2020 18:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 18:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839933
Page 125 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 02:26:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation -
updated PD tracker
Oct-19-2020 11:25:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarQuery 1: Answered DATA IS
CORRECT
Oct-19-2020 06:31:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at this
visit is out of
window (2 day)
from DOV (08/Sep
/2020) at
V2_VAX2_L. Please
reconcile and update
accordingly, else
confirm date is
correct as is.
Oct-16-2020 09:22:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/15/2020Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839934
Page 126 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 09:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 09:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 09:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 09:24:38
(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-16-2020 09:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 09:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BR2Z39Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839935
Page 127 of 192
***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: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 09:24:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR2Z39Initial Entry
5.b
Date Location User Value Reason
Oct-16-2020 09:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHRS5Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 09:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRS5Initial Entry
5.c
Date Location User Value Reason
Oct-16-2020 09:25:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHRS6Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 09:25:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRS6Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839936
Page 128 of 192
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021 09:39:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Mar/4/2021Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839937
Page 129 of 192
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-05-2021 09:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-05-2021 09:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021 09:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-05-2021 09:40:14
(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.
Mar-05-2021 09:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Mar/4/2021Initial Entry
5.a
Date Location User Value Reason
Mar-05-2021 09:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BRLYFJInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839938
Page 130 of 192
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Mar-05-2021 09:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BRLYFJInitial Entry
5.b
Date Location User Value Reason
Mar-05-2021 09:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BS9FWXInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-05-2021 09:48:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BS9FWXInitial Entry
5.c
Date Location User Value Reason
Mar-05-2021 09:48:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BS9FWWInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-05-2021 09:48:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BS9FWWInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839939
Page 131 of 192
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020 09:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 09:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 09:25:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839940
Page 132 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839941
Page 133 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839942
Page 134 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839943
Page 135 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839944
Page 136 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839945
Page 137 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839946
Page 138 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839947
Page 139 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-09-2020 00:02:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Sep-08-2020 18:08:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered IF THIS WAS
CONSIDERED A
COVID-19
ILLNESS
RELATED EVENT
THERE WOULD
ALSO BE A
POTENTIAL
COVID-19 FORM
COMPLETED,
BUT IT WAS NOT.
Sep-07-2020 23:46:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Per protocol
Amendment 5 -
Section 8.3.7.,
COVID-19 related
listed event should
be please
documented ONLY
on the COVID
Illness CRF form
regardless of other
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839948
Page 140 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
potential diagnosis.
A Nasal Swab will
not be collected (the
symptom ended on
30Aug2020).
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SORE THROATInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-03-2020 17:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 17:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/23/2020 UNK:UNKTranscription Error
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For SORE
THROAT Start Date
23/Sep/2020, is a
future date relative
to when it was
entered on 03/Sep
/2020. Please
correct.
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-03-2020 17:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For SORE
THROAT End Date
& Time
30/Aug/2020
UNK:UNK is
before the Start
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839949
Page 141 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date & Time
23/Sep/2020
UNK:UNK.
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/30/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839950
Page 142 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
OTHER
If Other, specify:
UNRELATED NEW MED
ICAL CONDITION
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-03-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839951
Page 143 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
02:26:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Nov-04-2020
11:46:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered YES, YOU ARE CORRECT.
THE WRONG ADVERSE
EVENT TERM WAS CHANGE.
Nov-04-2020
11:46:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
SUBARACHNOID H
EMORRHAGEYES, YOU ARE CORRECT.
THE WRONG ADVERSE
EVENT TERM WAS CHANGE.
Nov-04-2020
05:55:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 3: Reissued:Op
enedSAE RECON 1: Please review
the SAE terms reported in AE
CRF. AE#6 is recorded as right
frontal lobe hemorrhagic
contusion (grade 3)”.Please
confirm if AE#2 should be
updated to 'SUBARACHNOID
HEMORRHAGE' and AE#6 to
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839952
Page 144 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
'TRAUMATIC
INTRACRANIAL
HEMORRHAGE
Nov-03-2020
12:21:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 3: Answered THESE ARE TWO DIFFERENT
AES. TRAUMATIC
INTRACRANIAL
HEMORRHAGE REPLACED
THE TERM OF “right frontal
lobe hemorrhagic contusion
(grade 3)”.
Nov-03-2020
06:49:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020391390,AE#2
term was updated to 'traumatic
Intracranial hemorrhage' however,
in SDB, the event
'SUBARACHNOID
HEMORRHAGE' was still
recorded.Also, AE#6 is coded to
'traumatic Intracranial
hemorrhage'.Please clarify events
reported.
Nov-02-2020
12:55:01
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Closed Thank you.
Oct-30-2020
12:55:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
TRAUMATIC INTR
ACRANIAL HEMOR
RHAGEChanged Information
Oct-30-2020
12:11:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered IN PROCESS
Oct-29-2020
18:24:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Reissued:Op
enedAppreciate the response.
However, this study is assessing
the IMMUNOGENICITY, AND
EFFICACY OF SARS-COV-2
RNA VACCINE CANDIDATES
AGAINST COVID-19 IN
HEALTHY ADULTS. Kindly,
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839953
Page 145 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
record in the SAE report if Covid
test was negative/not
performed/Unknown. Thanks
Oct-23-2020
11:44:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered THE INFORMATION YOU ARE
REQUESTING IS NOT
RELEVANT TO THE EVENT.
Oct-22-2020
13:44:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Reissued:Op
enedIf test was NOT performed or
NOT available, please add this
information as well so it is
reflected in the SAE case
narrative. Thank you.
Oct-21-2020
14:30:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered THE HOSPITALIZATION WAS
NOT COVID-19 NOR EVEN
RESPIRATORY RELATED. IF A
COVID-19 TEST WAS DONE,
IT WOULD HAVE BEEN
ADDED TO THE SAE REPORT.
Oct-21-2020
11:34:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Opened COVID testing has not been
reported in the SAE submitted to
safety. Please submit a follow-up
SAE form to provide whether
COVID testing was performed
during hospitalization (yes/no)
and if yes, the results. Thank you.
Oct-20-2020
03:03:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-19-2020
14:28:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Oct-19-2020
14:28:28
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
SUBARACHNOID H
EMORRHAGEChanged Information
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839954
Page 146 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-19-2020
07:11:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020391390,term
was updated to 'right frontal lobe
hemorrhagic contusion', 'fracture
of the roof of the right orbital' and
'right frontal lobe hemorrhagic
contusion' in Safety
database.Please confirm if should
be recorded as SAEs in AE CRF.
Oct-12-2020
15:16:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
HEAD TRAUMAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 08:20Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020 14:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/17/2020 UNK:UNKNew Information
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020 11:52:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Changed
Information
Oct-19-2020 18:12:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839955
Page 147 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-19-2020 14:29:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-19-2020 14:29:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Changed
Information
Oct-19-2020 14:00:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
evaluate AE grade
based on Protocol
10.3.3 and make
change as
appropriate.
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 11:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Closed Thank you!
Oct-26-2020 19:52:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed
Information
Oct-26-2020 19:52:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NOChanged
Information
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839956
Page 148 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
YES
Other medically important ser
ious event
NO
Oct-21-2020 23:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Opened The subarchanoid
hemorrhage was
reported to be life
threatening.
However, in the case
narrative of SDB it
currently reads
"mild" and "grade
3". Please
confirm/update AE
log or Case narrative
with FU form if
approprriate.
Oct-19-2020 14:30:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NONew Information
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839957
Page 149 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
YES
Oct-12-2020 20:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 15:17:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-12-2020 15:17:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YESNew Information
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839958
Page 150 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NO
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria
is missing. Please
review and update as
appropriate.
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE HEAD
TRAUMA:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event require
or prolong hospitalization?
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839959
Page 151 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-30-2020 18:18:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-30-2020 13:03:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Oct-30-2020 13:03:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
FALL FROM BICYCL
EChanged Information
Oct-28-2020 11:37:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened ClinQuery3: The
accident would not be
ongoing as the injuries
inflicted could be.
CTCAE does have fall
listed of Grades 1-3.
The other responses
would not be based on
the injuries. Each
injury will have its
own actions. Hope this
helps. Thanks.
Oct-27-2020 17:11:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered IN REGARDS TO
STOP DATE,
INTENSITY,
CON-MED GIVEN,
DO WE BASE
THESE ANSWERS
ON THE
TRAUMATIC
INJURY THAT THE
BICYCLE
ACCIDENT
CAUSED?
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839960
Page 152 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
TECHNICALLY, THE
BICYCLE CRASH
ISN’T TREATED
WITH DRUGS OR
CAUSE
DISCONTINUATION,
HOWEVER THE
TRAUMATIC
INJURIES MAY.
Oct-20-2020 16:21:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened ClinQuery2: Thanks
for responding. If the
traumatic accident was
[either a fall or the
driver in a MVA], then
[fall &/or MVA] needs
to be reported as AE
also, even if an injury
didn't result. See CCGs
[8.49.2.2) & consider
adding Bicycle
Accident as an AE
Oct-17-2020 16:23:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered PER CRF
COMPLETION
GUIDELINE V7.0,
"When recording
traumatic injury other
than motor vehicle
accident when the
Participant is the
operator or falls as an
AE, record the injury
rather than the cause."
Oct-16-2020 18:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: Per the
Safety group, a
Bicycle Accident
should be treated like a
fall. Please enter a new
AE for Bicycle
Accident to update the
CRF as appropriate.
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0839961
Page 153 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-14-2020
04:52:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Closedper site response
Oct-13-2020
13:28:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
AnsweredPER CRF
COMPLETION
GUIDELINE,
THIS IS THE
APPROPRIATE
ENTRY
MEDTHOD
"WHEN
RECORDING
TRAUMATIC
INJURY
OTHER THAN
MOTOR
VEHICLE
ACCIDENT
WHEN THE
PARTICIPANT
IS THE
OPERATOR OR
FALLS AS AN
AE, RECORD
THE INJURY
RATHER
THAN THE
CAUSE."
Oct-13-2020
00:27:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedPlease review
"If not related to
study treatment
other" field, the
following text
was indicated in
the comment
field [bicycle
accident]. Any
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839962
Page 154 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
symptoms, AEs
or other key data
should be
collected on the
appropriate
page. If this is
Fall Please
review and
update as
necessary as per
guidelines.
Oct-12-2020
15:16:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
NOT REL
ATED
If Not R
elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Ot
her, s
pecif
y:
BIC
YC
LE
AC
CID
EN
TInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020 15:16:19 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839963
Page 155 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)NOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-20-2020 08:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-19-2020 14:30:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered ADDED
Oct-18-2020 07:52:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM query2: Data
point 12 is missing,
Kindly review and
update.
Oct-17-2020 16:27:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-17-2020 16:27:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESNew Information
Oct-14-2020 07:15:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for Data item#11
and 12 are missing.
Kindly review and
update.
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020 14:30:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-19-2020 14:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839964
Page 156 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-19-2020 14:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-19-2020 14:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
SUBARACHNOID
HEMORRHAGE:
Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-12-2020 15:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-12-2020 20:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020391390Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839965
Page 157 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PARTIAL TEAR OF THE RIG
HT TRAPEZIUS MUSCLE (GR
ADE 1)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 17:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
NO
End Date Time:
Mar/4/2021 UNK:UNKNew Information
Jan-07-2021 11:02:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839966
Page 158 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-06-2021 13:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered ONGOING
Jan-05-2021 17:46:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
verify if PARTIAL
TEAR OF THE
RIGHT
TRAPEZIUS
MUSCLE (GRADE
1) is ongoing, then
update the END
DATE and
OUTCOME as
appropriate.
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-02-2021 12:16:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-02-2021 12:12:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered THE AE TERM
NOTES GRADE 1
BECAUSE THAT
IS WHAT THE
HOSPITAL
NOTED IN THE
RECORDS.
GRADE 2 IS
NOTED IN THE
INTENSITY
SECTION
BECAUSE THAT
IS THE PI
DECISION.
Feb-01-2021 15:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Grade 2
is entered. However
AE Term notes
Grade 1. Please
reconcile grade and
update the CRF as
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839967
Page 159 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
appropriate.
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
BICYCLE ACCIDENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839968
Page 160 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-04-2021 17:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-04-2021 17:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
RECOVERED/RESOLVEDNew Information
Mar-04-2021 17:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE PARTIAL
TEAR OF THE
RIGHT TRAPEZIUS
MUSCLE (GRADE
1): Response to "What
was the outcome of
this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839969
Page 161 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-19-2020 14:32:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839970
Page 162 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-28-2020 16:29:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Closed Response satisfies
query
Oct-23-2020 12:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered THE
INVESTIGATOR
DID NOT
CONSIDER THEM
EITHER
RELEVANT OR
DIRECTLY
RELATED TO
ALREADY
SUBMITTED AES
OR MH.
Oct-21-2020 22:33:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Opened Additional adverse
events are noted in
the case narrative:
right upper eyelid
hematoma, right (R)
shoulder and R hip
pain, possible
brachial plexus
traction. Please
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839971
Page 163 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
revise/update AE log
with additional
events if appropriate.
Thank you.
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WIDENINNG OFACROMIO
CLAVICULAR JOINT SPACE
(GRADE 1)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021
17:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
NO
End Date Time:
Mar/4/2021 UNK:UN
KNew Information
Jan-07-2021 14:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Jan-06-2021 13:04:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered ONGOING
Jan-05-2021 17:47:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please verify if
WIDENINNG
OFACROMIOCLAVICULAR
JOINT SPACE (GRADE 1) is
ongoing, then update the END
DATE and OUTCOME as
appropriate.
Oct-19-2020
14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839972
Page 164 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Feb-02-2021 12:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-02-2021 12:12:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered THE AE TERM
NOTES GRADE 1
BECAUSE THAT
IS WHAT THE
HOSPITAL
NOTED IN THE
RECORDS.
GRADE 2 IS
NOTED IN THE
INTENSITY
SECTION
BECAUSE THAT
IS THE PI
DECISION.
Feb-01-2021 15:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Grade 2
is entered. However
AE Name notes
Grade 1. Please
reconcile grade and
update the CRF as
appropriate.
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839973
Page 165 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
BICYCLE ACCIDENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839974
Page 166 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Mar-04-2021
17:03:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-04-2021
17:03:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
RECOVERED/RESOLV
EDNew Information
Mar-04-2021
17:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE WIDENINNG
OFACROMIOCLAVICULAR
JOINT SPACE (GRADE 1):
Response to "What was the
outcome of this adverse
event?" is
'Recovering/Resolving' but
AE End Date/Time is present.
Oct-19-2020
14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 14:34:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839975
Page 167 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FRACTURE OF ROOF OF RIG
HT ORBITAL (GRADE 3)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-16-2020 15:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
NO
End Date Time:
Dec/14/2020 UNK:UNKNew Information
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839976
Page 168 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-20-2020 03:04:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 14:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-19-2020 14:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th 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 disabil
ity/incapacity?
NONew Information
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839977
Page 169 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
NO
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least
one seriousness
criteria is missing.
Please review and
update as
appropriate.
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
FRACTURE OF
ROOF OF RIGHT
ORBITAL
(GRADE 3):
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event require
or prolong hospitalization?
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839978
Page 170 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
BICYCLE ACCIDENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-22-2020
08:20:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed sdb updated
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0839979
Page 171 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-18-2020
07:46:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Reissued:C
andidatePending SDB update
Dec-17-2020
15:46:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector Aguilar Query 2: Answered SAE FOLLOW-UP HAS BEEN
UPDATED.
Dec-17-2020
07:27:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020391390,outcome
was updated to
RECOVERED/RESOLVED on AE
CRF while reported as Not
Recovered/Not Resolved in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form
Dec-16-2020
15:46:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-16-2020
15:46:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
RECOVERED/RES
OLVEDNew Information
Dec-16-2020
15:45:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE FRACTURE OF ROOF OF
RIGHT ORBITAL (GRADE 3):
Response to "What was the outcome
of this adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Oct-19-2020
14:35:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED
/NOT RESOLVEDInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839980
Page 172 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 14:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-20-2020 03:04:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020391390Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0839981
Page 173 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-04-2020 11:50:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TRAUMATIC INTRACRANI
AL HEMORRHAGEChanged Information
Oct-27-2020 23:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-27-2020 17:27:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered QUERY HAS BEEN
RESOLVED
Oct-27-2020 06:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened term coding updated
in SDB. issue resolved
Oct-22-2020 00:01:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate SAE RECON:
Pending discussion
with Clinical
Oct-21-2020 15:01:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered PLEASE CLARIFY
WHAT "CODED IN
THE SAFETY
DATABASE"
MEANS. SITE
STAFF DO NOT
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839982
Page 174 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
HAVE ACCESS TO
A SAFETY
DATABASE.
Oct-20-2020 23:32:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020391390,the
term in Safety
database was coded to
BRAIN CONTUSION
and CEREBRAL
CONTUSION. Per
Clinical review, please
consider to record the
event as separate
entries to match Safety
database reported
events.
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHT FRONTAL LOBE H
EMORRHAGIC CONTUSIO
N (GRADE 3)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 17:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
NO
End Date Time:
Mar/4/2021 UNK:UNKNew Information
Jan-07-2021 14:19:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-06-2021 13:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered ONGOING
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839983
Page 175 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-05-2021 17:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
verify if Traumatic
Intracranial
Hemorrhage is
ongoing, then
update the END
DATE and
OUTCOME as
appropriate.
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-20-2020 03:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE RIGHT
FRONTAL LOBE
HEMORRHAGIC
CONTUSION
(GRADE 3):
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839984
Page 176 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839985
Page 177 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-22-2020
08:40:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: Cl
osedClinical query
created for
Bicycle
accident prior
to SDQ query
firing. Since
similar query
already
present,
closing this
query.
Oct-20-2020
08:01:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: O
penedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in the
comment field
[bicycle
accident]. Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. Please
review and
update as
necessary.
Oct-19-2020
14:37:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entry
:
NOT RELA
TED
If Not Rel
ated to stu
dy treatm
ent(s), thi
s event is
due to:
OTHERInitial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839986
Page 178 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
If Othe
r, speci
fy:
BIC
YCL
E AC
CIDE
NT
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021
04:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Candid
atePending SDB update
Mar-10-2021
15:43:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 2: Answered THE SAFTEY DATABASE
HAS BEEN UPDATED
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839987
Page 179 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-10-2021
07:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020391390
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/Resolving in
Safety database. Please
confirm correct outcome.If
safety update is
required,please submit ffup
form
Mar-04-2021
17:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-04-2021
17:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
RECOVERED/RESOLVE
DNew Information
Mar-04-2021
17:04:11 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE TRAUMATIC
INTRACRANIAL
HEMORRHAGE:
Response to "What was the
outcome of this adverse
event?" is
'Recovering/Resolving' but
AE End Date/Time is
present.
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLV
INGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 14:37:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0839988
Page 180 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-20-2020 03:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020391390Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839989
Page 181 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FALL FROM BICYCLEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 08:20Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/6/2020 08:20Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0839990
Page 182 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
NO UNDERLYING CAU
SEInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-30-2020 13:02:31 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30c3\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0839991
Page 183 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561001 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)NOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-30-2020 13:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location Use
…[truncated]