125742 S1 M5 CRF c4591001 1156 11561007

Document text

Page 1 of 168
***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: 11561007 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
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840464
Page 2 of 168
***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: 11561007 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/20/2020
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840465
Page 3 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561007]
2.Birth Date: /1998
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840466
Page 4 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840467
Page 5 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840468
Page 6 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840469
Page 7 of 168
***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: 11561007 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:[Obesity]
Start Date: Jun/6/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Menorrhagia]
Start Date: Jan/3/2020
Ongoing: NO
End Date:
Jan/20/2020
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[C-section]
Start Date: May/16/2019
Ongoing: NO
End Date:
May/16/2019
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840470
Page 8 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [83.6]
3.Unit: kg
4.Height: [160.3]
5.Unit: cm
6.Body Mass Index: [32.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840471
Page 9 of 168
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/20/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840472
Page 10 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [58521]
3.Randomization Group: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840473
Page 11 of 168
***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: 11561007 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/20/2020
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 [BP184F]
5.bSample ID [BP184G]
5.cSample ID [BP184H]
5.dSample ID [BPHRX8]
5.eSample ID [BPHRX9]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840474
Page 12 of 168
***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: 11561007 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/20/2020
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 [BP184D]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840475
Page 13 of 168
***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: 11561007 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/20/2020 15:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840476
Page 14 of 168
***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: 11561007 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
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840477
Page 15 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840478
Page 16 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840479
Page 17 of 168
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840480
Page 18 of 168
***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: 11561007 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/10/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP18JW]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840481
Page 19 of 168
***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: 11561007 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/10/2020 16:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840482
Page 20 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840483
Page 21 of 168
***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: 11561007 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/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPHRP7]
5.bSample ID [BPHRP8]
5.cSample ID [BR2Z19]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840484
Page 22 of 168
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840485
Page 23 of 168
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840486
Page 24 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840487
Page 25 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840488
Page 26 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840489
Page 27 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840490
Page 28 of 168
***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: 11561007 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:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840491
Page 29 of 168
***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: 11561007 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: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840492
Page 30 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840493
Page 31 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840494
Page 32 of 168
***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: 11561007 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?
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840495
Page 33 of 168
***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: 11561007 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:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840496
Page 34 of 168
***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: 11561007 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:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840497
Page 35 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840498
Page 36 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840499
Page 37 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840500
Page 38 of 168
***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: 11561007 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/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840501
Page 39 of 168
***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: 11561007 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: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840502
Page 40 of 168
***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: 11561007 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:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840503
Page 41 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840504
Page 42 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
 1.ADVERS
E EVENT
 1  HEMOPTYSIS  Oct/4/2020
UNK:UNK
 NO
End Date Time:
Oct/4/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERS
E EVENT
 2  INCOMPLETE SPON
TANEOUS ABORTI
ON Oct/4/2020
UNK:UNK
 NO
End Date Time:
Oct/7/2020 UN
K:UNK
 Repeating
Pages
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840505
Page 43 of 168
***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: 11561007 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)[HEMOPTYSIS]
4.Start Date Time: Oct/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/4/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840506
Page 44 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[UNKNOWN ETIOLOGY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840507
Page 45 of 168
***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: 11561007 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[ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840508
Page 46 of 168
***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: 11561007 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)[INCOMPLETE SPONTANEOUS ABORTION]
4.Start Date Time: Oct/4/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/7/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840509
Page 47 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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:
[UNKNOWN ETIOLOGY]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840510
Page 48 of 168
***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: 11561007 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?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020389575]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840511
Page 49 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840512
Page 50 of 168
***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: 11561007 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[ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840513
Page 51 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840514
Page 52 of 168
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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.Date: //
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840515
Page 53 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840516
Page 54 of 168
***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: 11561007 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?
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840517
Page 55 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840518
Page 56 of 168
***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: 11561007 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?
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840519
Page 57 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840520
Page 58 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840521
Page 59 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840522
Page 60 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11561007 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:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840523
Page 61 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840524
Page 62 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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?
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840525
Page 63 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840526
Page 64 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840527
Page 65 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840528
Page 66 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840529
Page 67 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840530
Page 68 of 168
***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: 11561007 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 [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840531
Page 69 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840532
Page 70 of 168
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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 per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840533
Page 71 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/1/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840534
Page 72 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840535
Page 73 of 168
***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: 11561007 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: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840536
Page 74 of 168
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840537
Page 75 of 168
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840538
Page 76 of 168
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840539
Page 77 of 168
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840540
Page 78 of 168
***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: 11561007 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/12/2020
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840541
Page 79 of 168
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840542
Page 80 of 168
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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-02-2021 15:11:31 (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.
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840543
Page 81 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-20-2020 16:42:47 (UTC-05:00)
Eastern Time (US & Canada)Hector
AguilarNot Applicable
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840544
Page 82 of 168
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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-02-2021 15:11:31 (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 Mar-01-2021 14:55:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-03-2020 14:15:47 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840545
Page 83 of 168
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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.
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840546
Page 84 of 168
***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: 11561007 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-20-2020
16:41:50
(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-20-2020
16:41:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840547
Page 85 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020
16:41:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/20/2020Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840548
Page 86 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020
16:41:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11561007Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-09-2020
06:08:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Oct-08-2020
18:43:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answere
dTHE SAE FORM
SUBMITTED ON
07-OCT-2020 IS NOT
MISSING ANY OF THE
INFORMATION THAT
YOU'RE SUGGESTING. I
HAVE REVIEW AND
CONFIRMED THAT ALL
REQUIRE
INFORMATION WAS
ENTERED.
Oct-08-2020 ACV0PFEINFP6000  Query 1: SAE
090177e196ae30c4\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-2021-5683-0840549
Page 87 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
06:41:15
(UTC-05:00)
Eastern Time
(US &
Canada)Opened RECON:AER#2020389575
,the date of birth was
missing in Safety database
but was recorded as 
/1998in AE CRF.Please
confirm if date of birth was
reported.If safety update is
required, please submit a
follow-up form
Aug-20-2020
16:41:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data En
try:
1
998Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-09-2020
06:08:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Oct-08-2020
18:40:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answere
dTHE GENDER WAS
SELECTED AS FEMALE
ON PAGE 1 OF VACCINE
SAE REPORTING FORM
INITIAL SUBMITTED
07-0CT-2020.
Oct-08-2020
06:42:33ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2020389575
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0840550
Page 88 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US &
Canada),the gender was missing in
Safety database but was
recorded as FEMALE in
AE CRF.Please confirm if
gender was reported.If
safety update is required,
please submit a follow-up
form
Aug-20-2020
16:42:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data En
try:
FEMAL
EInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020
16:42:12
(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-20-2020
16:42:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840551
Page 89 of 168
***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: 11561007 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-20-2020
16:42:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/20/2020Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840552
Page 90 of 168
***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: 11561007 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-20-2020
16:43:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020
16:43:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020
16:43:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840553
Page 91 of 168
***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: 11561007 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
16:43:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Obesit
y
Start Date: Jun/6/
2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:43:53
(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-20-2020
16:43:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ObesityInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840554
Page 92 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.a Start Date:
Date Location User Value Reason
Aug-20-2020
16:43:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Jun/6/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020
16:43:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-20-2020
16:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Menorrh
agia
Start Date: Jan/3/20
20Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840555
Page 93 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Da
te:
Jan/2
0/202
0
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840556
Page 94 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:44:38
(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-20-2020
16:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
MenorrhagiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-20-2020
16:44:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Jan/3/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-20-2020
16:44:38ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840557
Page 95 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
Jan/20/2020
1.c
Date Location User Value Reason
Aug-20-2020
16:45:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term
:C-section
Start Date: May/16/2
019
Ongoing: NO
End Dat
e:
May/1
6/2019Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840558
Page 96 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Aug-20-2020
16:45:19
(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-20-2020
16:45:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
C-sectionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-20-2020
16:45:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
May/16/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-20-2020
16:45:19ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840559
Page 97 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
May/16/2019
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840560
Page 98 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
83.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840561
Page 99 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
160.3Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.5Initial Entry
7.a
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Ide
ntifier::1
Temperatu
re:96.6Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840562
Page 100 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020
07:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Per site's
confirmation.
Aug-21-2020
09:19:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarQuery 1: Answered not clinically
significant
Aug-21-2020
06:48:52
(UTC-05:00)ACV0PFEINFP6000  Query 1: Reissued:
OpenedDM:
Confirmation
on the out of
090177e196ae30c4\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-2021-5683-0840563
Page 101 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)range value as
clinically
significant or
not is expected.
Please review
and confirm.
Aug-20-2020
17:00:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarQuery 1: Answered Original value
is correct
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature
96.6 F is
outside of
Normal Range
97 - 99.5 F.
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
96.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840564
Page 102 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020
16:46:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840565
Page 103 of 168
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840566
Page 104 of 168
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840567
Page 105 of 168
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020
16:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEGATIVEInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840568
Page 106 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020
16:46:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020
16:46:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
58521Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840569
Page 107 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020
16:46:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
16:46:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020
16:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-20-2020
16:46:47
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840570
Page 108 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-20-2020
16:46:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
16:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP184
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020
16:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP184FInitial Entry
5.b
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840571
Page 109 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-20-2020
16:47:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP184
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020
16:47:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP184GInitial Entry
5.c
Date Location User Value Reason
Aug-20-2020
16:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP184
HInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840572
Page 110 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Aug-20-2020
16:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP184HInitial Entry
5.d
Date Location User Value Reason
Aug-20-2020
16:47:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample I
D:BPHRX
8Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-20-2020
16:47:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRX8Initial Entry
5.e
Date Location User Value Reason
Aug-20-2020
16:47:52ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample I BPHRXInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840573
Page 111 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)D: 9
5.e Sample ID
Date Location User Value Reason
Aug-20-2020
16:47:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRX9Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840574
Page 112 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020
16:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020
16:49:24
(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-20-2020
16:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-20-2020
16:49:24
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840575
Page 113 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-20-2020
16:49:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020
16:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP184
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020
16:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP184DInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840576
Page 114 of 168
***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: 11561007 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-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840577
Page 115 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Aug/20/2020 15:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020
16:50:52
(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-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840578
Page 116 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-20-2020
16:50:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840579
Page 117 of 168
***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: 11561007 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
10:09:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTTranscription
Error
Aug-20-2020
16:51:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840580
Page 118 of 168
***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: 11561007 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-10-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/10/2020Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840581
Page 119 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
16:19:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/10/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020
16:19:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Ide
ntifier::1
Temperatu
re:98.5
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
16:19:16
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840582
Page 120 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-10-2020
16:19:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
98.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020
16:19:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
16:19:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840583
Page 121 of 168
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840584
Page 122 of 168
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840585
Page 123 of 168
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020
16:19:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEGATIVEInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840586
Page 124 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
16:47:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
16:47:02
(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-10-2020
16:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
16:47:02
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840587
Page 125 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-10-2020
16:47:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
16:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BP18J
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
16:47:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18JWInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840588
Page 126 of 168
***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: 11561007 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-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840589
Page 127 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/10/2020 16:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840590
Page 128 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-10-2020
16:20:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840591
Page 129 of 168
***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: 11561007 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-12-2020
17:00:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/12/2020Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840592
Page 130 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
18:38:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
18:38:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
18:39:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
18:38:57
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840593
Page 131 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-12-2020
18:38:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection
:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
18:39:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BPHRP
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
18:39:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRP7Initial Entry
5.b
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840594
Page 132 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-12-2020
18:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BPHRP
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
18:39:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHRP8Initial Entry
5.c
Date Location User Value Reason
Oct-12-2020
18:39:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID
:BR2Z1
9Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840595
Page 133 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
18:39:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR2Z19Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840596
Page 134 of 168
***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: 11561007 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-12-2020
17:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020
17:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020
17:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840597
Page 135 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840598
Page 136 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840599
Page 137 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020
16:54:35
(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-07-2020
16:54:35
(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
Oct-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEMOPTYSISInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840600
Page 138 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/4/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/4/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020
16:54:35
(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).
090177e196ae30c4\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-2021-5683-0840601
Page 139 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-09-2020
10:17:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Close
dResponse satisfies
query
Oct-08-2020
18:49:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredTHIS IS A
TRANSCRIPTION
OF THE PI'S
ASSESSMENT
OF
SERIOUSNESS
CRITERIA.
Oct-08-2020
14:41:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Open
edGPDClin: Please
provide PI's
assessment on if it
was a medically
important event. If
yes, a SAE report
is required. If it is
considered related
to the SAE of
abortion, e.g., same
underlying cause, it
can be added as the
2nd term for the
same SAE report.
Oct-07-2020
16:54:35
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c4\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-2021-5683-0840602
Page 140 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US & Canada)
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-07-2020
16:54:35
(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-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to s
tudy treatment(s),
this event is due to
:
OTHER
If Other, specify
:
UNKNOWN
ETIOLOGYInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840603
Page 141 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020
16:54:35
(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-07-2020
16:54:35
(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-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
090177e196ae30c4\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-2021-5683-0840604
Page 142 of 168
***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: 11561007 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-07-2020
16:54:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840605
Page 143 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020
16:55:55
(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-07-2020
16:55:55
(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
Dec-03-2020
12:55:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Cl
osedAnswer was send in
error. Response satisfy
query = yes.
Apologies. Thank
you.
Dec-03-2020
12:29:57ACV0PFEINFP6000  Hector Aguilar Query 3: An
sweredQuery is ambiguous
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840606
Page 144 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time
(US & Canada)
Dec-03-2020
02:33:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edResponse does not
satisfy query
Dec-02-2020
18:59:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Re
issued:Cand
idateResponse does not
satisfy query
Dec-02-2020
10:50:14
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 3: An
sweredAE OF
HEMOPTYSIS HAS
ALREADY BEEN
ADDED
Dec-01-2020
15:02:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Op
enedThe case narrative
records that the
subject presented to
the ER with pelvic
pain and
"hemoptysis". Please
confirm AE of
hemoptysis and if so,
the subsequent
work-up.
Nov-02-2020
12:55:01
(UTC-05:00)ACV0PFEINFP6000  Giselle Castillo Query 2: Cl
osedThank you.
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840607
Page 145 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time
(US & Canada)
Oct-30-2020
12:10:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredIN PROCESS
Oct-29-2020
18:25:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Re
issued:Open
edAppreciate 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, record in the
SAE report if Covid
test was negative/not
performed/Unknown.
Thanks
Oct-23-2020
12:18:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredSAE WAS
SUBMITTED
CORRECTLY
USING THE SAE
JOB GUIDE
PROVIDED BY
PFIZER. IF THE
SPONSOR
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840608
Page 146 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
REQUIRES THE
GATHERING OF
SPECIFIC INFO, IT
SHOULD BE
PROVIDED IN A
FORMAL
DOCUMENT TO
AVOID
UNNECESSARY
WORK FOR SITES.
Oct-22-2020
14:28:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Re
issued:Open
edIf 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
14:34:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredIF A COVID-19
TEST WAS DONE,
IT WOULD HAVE
BEEN ADDED TO
THE SAE REPORT.
Oct-21-2020
11:34:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Op
enedCOVID 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,
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840609
Page 147 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
the results. Thank
you.
Oct-16-2020
10:18:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies
query
Oct-16-2020
09:47:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredTHIS HAS BEEN
REPORTED
SEVERAL TIMES
Oct-15-2020
01:56:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Op
enedClinQuery: If
Exposure During
Pregnancy occurs in a
subject or subject's
partner, the
investigator must
report this to Pfizer
Safety on the Vaccines
SAE report Form and
an EDP supplemental
form. Please confirm
the EDP supplemental
form was completed.
Oct-14-2020
15:29:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ca
ndidateClinQuery: If
Exposure During
Pregnancy occurs in a
subject or subject's
partner, the
investigator must
090177e196ae30c4\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-2021-5683-0840610
Page 148 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
report this to Pfizer
Safety on the Vaccines
SAE report Form and
an EDP supplemental
form. Please confirm
the EDP supplemental
form was completed.
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
INCOMPLE
TE SPONT
ANEOUS A
BORTIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-04-2020
16:08:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Closed Response
satisfies query
Dec-03-2020
12:33:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answe
redSAE REPORT
REFERS TO
CONCEPTION,
BUT THE AE
REFERS TO
INCOMPLETE
SPONTANEOUS
ABORTION.
THEY ARE
TWO
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840611
Page 149 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
DIFFERENT
THINGS, WITH
TWO
SEPERATE
START DATES.
Dec-02-2020
19:33:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reissu
ed:OpenedThank you for
your response.
The SAE report
submitted to
safety (case
narrative) records
a date of
conception of
Aug 2020.
Kindly revise and
update onset date
accordingly.
Thank you
Dec-02-2020
11:25:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answe
redPLEASE
ADVISE
WHERE IN THE
SOURCE IS
THE CASE
NARRATIVE
TO WHICH
YOU REFER.
Dec-01-2020
15:01:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Opene
dPer case
narrative, the
date of
conception is
Aug 2020.
Kindly revise and
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840612
Page 150 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
update onset date
accordingly.
Thank you.
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/4/2020 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-09-2020
15:18:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 UN
K:UNKNew
Information
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae30c4\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-2021-5683-0840613
Page 151 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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-08-2020
06:36:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candi
dateFor AE
INCOMPLETE
SPONTANEOUS
ABORTION:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious
event associat
ed with conge
nital anomalyInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840614
Page 152 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
or birth defect
?
NO
Did this seriou
s event result i
n death?
NO
Did this seriou
s event require
or prolong hos
pitalization?
NO
Did this seriou
s event result i
n persistent or
significant dis
ability/incapac
ity?
NO
Is this serious
event life thre
atening?
NO
Other medicall
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840615
Page 153 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
y important se
rious event
YES
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-07-2020
16:55:55
(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-09-2020
06:09:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
ClosedResponse satisfies query
Oct-08-2020
18:48:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answere
dTHE SAE FORM
SUBMITTED ON
07-OCT-2020 IS NOT
MISSING ANY OF THE
INFORMATION THAT
YOU'RE SUGGESTING. I
HAVE REVIEWED AND
CONFIRMED THAT ALL
090177e196ae30c4\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-2021-5683-0840616
Page 154 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
REQUIRED
INFORMATION WAS
ENTERED. I'M QUITE
CONFUSED AS TO
WHAT DOCUMENT
YOU ARE
REFERENCING.
Oct-08-2020
06:44:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2020389575
,the causality was recorded
as NO DATA in Safety
database but was recorded
as NOT RELATED in AE
CRF.Please confirm correct
causality.If safety update is
required, please submit a
follow-up form
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
NOT RE
LATED
If Not
Related
to study
treatme
nt(s), th
is event
is due t
o:
OTHE
RInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0840617
Page 155 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
If Ot
her,
speci
fy:
U
N
K
N
O
W
N
ET
IO
LO
G
Y
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-09-2020
06:09:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
ClosedResponse satisfies query
Oct-08-2020
18:47:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
Answere
dTHE SAE FORM
SUBMITTED ON
07-OCT-2020 IS NOT
MISSING ANY OF THE
INFORMATION THAT
YOU'RE SUGGESTING. I
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0840618
Page 156 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
HAVE REVIEWED AND
CONFIRMED THAT ALL
REQUIRED
INFORMATION WAS
ENTERED. I'M QUITE
CONFUSED AS TO
WHAT DOCUMENT
YOU ARE
REFERENCING.
Oct-08-2020
06:46:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2:
OpenedSAE
RECON:AER#2020389575
,the Action taken was
missing in Safety database
but was recorded as NOT
APPLICABLE in AE
CRF.Please confirm correct
action taken.If safety
update is required, please
submit a follow-up form
Oct-08-2020
06:45:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Closedcorrected query text
Oct-08-2020
06:43:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2020389575
,the Action taken was
missing in Safety database
but was recorded as NOT
APPLICABLE in AE
CRF.Please confirm correct
090177e196ae30c4\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-2021-5683-0840619
Page 157 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
outcome.If safety update is
required, please submit a
follow-up form
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
NOT AP
PLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020
16:55:55
(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-07-2020
16:55:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae30c4\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-2021-5683-0840620
Page 158 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-12-2020
05:48:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response
satisfies query.
Oct-12-2020
05:14:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-11-2020
17:24:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answer
edAnswer Auto
Query
Oct-11-2020
17:24:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/R
ESOLVEDNew
Information
Oct-10-2020
08:03:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissue
d:OpenedPer response
"UPDATED";
however data is
not updated in
'What was the
outcome of this
adverse event'
or 'End Date'
field. Please
review the
data.
090177e196ae30c4\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-2021-5683-0840621
Page 159 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-09-2020
15:19:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 2
: Answ
eredUPDATED
Oct-09-2020
15:19:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Answ
eredUPDATED
Oct-09-2020
15:18:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2
: Opene
dFor AE INCOMPLETE
SPONTANEOUS
ABORTION: Response to
"What was the outcome of
this adverse event?" is 'Not
Recovered/Not Resolved'
but AE End Date/Time is
present.
Oct-09-2020
06:12:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Reissu
ed:Ope
nedSAE RECON 1: Outcome
was updated in Safety
database to
RECOVERED/RESOLVED
but retained as NOT
RECOVERED/NOT
RESOLVED in AE
090177e196ae30c4\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-2021-5683-0840622
Page 160 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
CRF.Please confirm correct
outcome.If safety update is
required, please submit a
follow-up form
Oct-08-2020
18:44:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Answ
eredOUTCOME WAS
UPDATED ON
FOLLOW-UP REPORT 1
SUBMITTED
08-OCT-2020
Oct-08-2020
06:45:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Opene
dSAE
RECON:AER#2020389575
,the outcome was missing in
Safety database but was
recorded as OT
RECOVERED/NOT
RESOLVED in AE
CRF.Please confirm correct
outcome.If safety update is
required, please submit a
follow-up form
Oct-07-2020
16:55:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
NOT R
ECOV
ERED/
NOT R
ESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae30c4\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-2021-5683-0840623
Page 161 of 168
***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: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-07-2020
16:55:55
(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-08-2020
06:36:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020389575Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0840624
Page 162 of 168
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 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-01-2021
14:55:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Mar/1/2021Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840625
Page 163 of 168
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-01-2021
14:56:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-01-2021
14:55:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Mar-01-2021
14:55:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible per loca
l/national recom
mendations and
confirmed to haInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840626
Page 164 of 168
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ve received only
placebo at Vacci
nation 1/2
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840627
Page 165 of 168
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-01-2021
14:56:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Mar/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-01-2021
14:56:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840628
Page 166 of 168
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020
17:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020
16:46:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-20-2020
16:43:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-12-2020
17:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
Aug-20-2020
16:46:32ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840629
Page 167 of 168
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-20-2020
16:43:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0840630
Page 168 of 168
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
14:08:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Click Here to EnableInitial Entry
090177e196ae30c4\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0840631