125742 S1 M5 CRF c4591001 1156 11561160

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
246
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 246
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 11561160 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841565
Page 2 of 246
***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: 11561160 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
Sep/21/2020
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841566
Page 3 of 246
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11561160]
2.Birth Date: /1958
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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841567
Page 4 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841568
Page 5 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841569
Page 6 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841570
Page 7 of 246
***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: 11561160 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:[human immunodeficiency virus disease]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cesarean section]
Start Date: Nov/11/1974
Ongoing: NO
End Date:
Nov/11/1974
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[newborn delivery]
Start Date: Nov/11/1974
Ongoing: NO
End Date:
Nov/11/1974
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cesarean section]
Start Date: Dec/20/1983
Ongoing: NO
End Date:
Dec/20/1983
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841571
Page 8 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[newborn delivery]
Start Date: Dec/20/1983
Ongoing: NO
End Date:
Dec/20/1983
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cesarean section]
Start Date: Dec/31/1987
Ongoing: NO
End Date:
Dec/31/1987
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[newborn delivery]
Start Date: Dec/31/1987
Ongoing: NO
End Date:
Dec/31/1987
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cesarean section]
Start Date: Oct/8/1991
Ongoing: NO
End Date:
Oct/8/1991
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841572
Page 9 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[newborn delivery]
Start Date: Oct/8/1991
Ongoing: NO
End Date:
Oct/8/1991
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anemia]
Start Date: Dec/5/2015
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: Dec/5/2015
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: Jan/31/2018
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic low back pain]
Start Date: Oct/8/2019
Ongoing: YES
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841573
Page 10 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: May/10/2017
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RHINITIS]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841574
Page 11 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is known to be HIV POSITIVE
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841575
Page 12 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [QUEST DIAGNOSTICS-MIAMI, 10200 COMMERCE PARKWAY, MIRAMAR,
FL 33025-3938 Laboratory Director: JULIE L FRIEDMAN,MD, CLIA:
10D0277334]
3.Collection Date: Aug/4/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [2124]
Test: HIV RNA (Ultrasensitive)
Result: [NOT DETECTED]
LNMT Low
[ ]
High
[<20]
Unit
/mL
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841576
Page 13 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [QUEST DIAGNOSTICS-MIAMI, 10200 COMMERCE PARKWAY, MIRAMAR,
FL 33025-3938 Laboratory Director: JULIE L FRIEDMAN,MD, CLIA:
10D0277334]
3.Collection Date: Aug/4/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [4722]
Test: CD4_PX4722
Result: [1.102]
LNMT Low
[0.49]
High
[1.74]
Unit
10^3/mm3
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841577
Page 14 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
2.Weight: [73.0]
3.Unit: kg
4.Height: [143.7]
5.Unit: cm
6.Body Mass Index: [35.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841578
Page 15 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841579
Page 16 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/21/2020
2.Randomization Number: [261932]
3.Randomization Group: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841580
Page 17 of 246
***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: 11561160 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:
Sep/21/2020
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 [BPHS77]
5.bSample ID [BPHS78]
5.cSample ID [BP18NG]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841581
Page 18 of 246
***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: 11561160 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/21/2020
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 [BP18NL]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841582
Page 19 of 246
***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: 11561160 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/21/2020 14:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841583
Page 20 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841584
Page 21 of 246
***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: 11561160 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
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841585
Page 22 of 246
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841586
Page 23 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841587
Page 24 of 246
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841588
Page 25 of 246
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841589
Page 26 of 246
***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: 11561160 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:
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 [BR2Z1S]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841590
Page 27 of 246
***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: 11561160 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: Oct/12/2020 15:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841591
Page 28 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841592
Page 29 of 246
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841593
Page 30 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Done Comments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841594
Page 31 of 246
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
HIV RNA (Ultrasensitive)
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841595
Page 32 of 246
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
CD4_PX4722
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841596
Page 33 of 246
***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: 11561160 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:
Nov/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 [BR69W7]
5.bSample ID [BRZPYP]
5.cSample ID [BRZPYR]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841597
Page 34 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841598
Page 35 of 246
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841599
Page 36 of 246
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841600
Page 37 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841601
Page 38 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841602
Page 39 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841603
Page 40 of 246
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841604
Page 41 of 246
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841605
Page 42 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841606
Page 43 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841607
Page 44 of 246
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841608
Page 45 of 246
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841609
Page 46 of 246
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11561160 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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841610
Page 47 of 246
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11561160 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: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841611
Page 48 of 246
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841612
Page 49 of 246
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841613
Page 50 of 246
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11561160 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?
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841614
Page 51 of 246
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 11561160 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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841615
Page 52 of 246
***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: 11561160 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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841616
Page 53 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841617
Page 54 of 246
***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: 11561160 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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841618
Page 55 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841619
Page 56 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841620
Page 57 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841621
Page 58 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  MOTOR VEHICLE AC
CIDENT Dec/24/2020 UNK
:UNK NO
End Date Time:
Dec/24/2020 UNK:UNK
 Repeating
Pages
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841622
Page 59 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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)[MOTOR VEHICLE ACCIDENT]
4.Start Date Time: Dec/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/24/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841623
Page 60 of 246
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2021018896]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841624
Page 61 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841625
Page 62 of 246
***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: 11561160 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[ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841626
Page 63 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841627
Page 64 of 246
***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: 11561160 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: //
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841628
Page 65 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841629
Page 66 of 246
***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: 11561160 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?
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841630
Page 67 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841631
Page 68 of 246
***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: 11561160 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?
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841632
Page 69 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841633
Page 70 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841634
Page 71 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841635
Page 72 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841636
Page 73 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841637
Page 74 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11561160 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:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841638
Page 75 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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?
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841639
Page 76 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841640
Page 77 of 246
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841641
Page 78 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841642
Page 79 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841643
Page 80 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841644
Page 81 of 246
***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: 11561160 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 [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841645
Page 82 of 246
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/24/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841646
Page 83 of 246
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841647
Page 84 of 246
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841648
Page 85 of 246
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841649
Page 86 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841650
Page 87 of 246
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Dec/24/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [MOTOR VEHICLE ACCIDENT]
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841651
Page 88 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/24/2020
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841652
Page 89 of 246
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841653
Page 90 of 246
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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-04-2021 12:47:18 (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.
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841654
Page 91 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-21-2020 16:57:32 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841655
Page 92 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-21-2020 17:23:40 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841656
Page 93 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841657
Page 94 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841658
Page 95 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841659
Page 96 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841660
Page 97 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Sep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841661
Page 98 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aSep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841662
Page 99 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aSep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841663
Page 100 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aSep-21-2020 17:23:40 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841664
Page 101 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841665
Page 102 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841666
Page 103 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841667
Page 104 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841668
Page 105 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841669
Page 106 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841670
Page 107 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841671
Page 108 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841672
Page 109 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6.aOct-13-2020 11:56:32 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841673
Page 110 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-11-2020 14:40:28 (UTC-05:00) Eastern
Time (US & Canada)Not Done
FormNov-10-2020 16:01:06 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841674
Page 111 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
1Nov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841675
Page 112 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2.aNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841676
Page 113 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.bNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2.bNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841677
Page 114 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.cNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2.cNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841678
Page 115 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.dNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2.dNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841679
Page 116 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.eNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2.eNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841680
Page 117 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2 fNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2 fNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841681
Page 118 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.gNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2.gNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841682
Page 119 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2 hNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
2 hNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841683
Page 120 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
3Nov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841684
Page 121 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Nov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
4Nov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841685
Page 122 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
5.aNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841686
Page 123 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
5.bNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841687
Page 124 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cNov-11-2020 14:40:28 (UTC-05:00) Eastern Time
(US & Canada)Not Done
5.cNov-10-2020 16:01:06 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841688
Page 125 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-10-2020 17:25:10 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841689
Page 126 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841690
Page 127 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Nov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841691
Page 128 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841692
Page 129 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Nov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841693
Page 130 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841694
Page 131 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841695
Page 132 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-10-2020 17:25:10 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841696
Page 133 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-10-2020 17:25:25 (UTC-05:00) Eastern
Time (US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841697
Page 134 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841698
Page 135 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Nov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841699
Page 136 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841700
Page 137 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Nov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841701
Page 138 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841702
Page 139 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841703
Page 140 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aNov-10-2020 17:25:25 (UTC-05:00) Eastern Time
(US & Canada)Hector Aguilar Not Applicable
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841704
Page 141 of 246
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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-04-2021 12:47:18 (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 Jan-28-2021 12:50:53 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Jan-23-2021 16:42:43 (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 Jan-14-2021 16:05:35 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-16-2020 15:44:01 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841705
Page 142 of 246
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, HectorRodriguez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-13-2020 16:23:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-12-2020 13:05:08 (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.
 N/A Nov-11-2020 14:40:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-11-2020 14:11:41 (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.
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0841706
Page 143 of 246
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Hector Aguilar  N/A Nov-10-2020 15:59:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Hector
Rodriguez Approved Nov-10-2020 12:15:27 (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.
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0841707
Page 144 of 246
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 11561160 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
Sep-21-2020 16:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-21-2020 16:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841708
Page 145 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-21-2020 16:56:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
OBTAINED
Date Written Consent Obtained
Sep/21/2020Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841709
Page 146 of 246
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-21-2020 16:56:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11561160Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-21-2020 16:56:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1958Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-21-2020 16:57:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-21-2020 16:57:10
(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
Sep-21-2020 16:57:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BLACK OR AFRICAN AMERIC
ANInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841710
Page 147 of 246
***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: 11561160 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-21-2020 16:57:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/21/2020Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841711
Page 148 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 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
Sep-21-2020 16:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-21-2020 16:57:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-21-2020 16:57:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
COMPLETEDInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841712
Page 149 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-21-2020 17:02:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:human immunodefici
ency virus disease
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:02:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020 10:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Oct-26-2020 19:58:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered STABLE
ANTIRETROVIRAL
THERAPY FOR
OVER THREE
YEARS.
Oct-26-2020 18:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: In addition
to viral load <50
copies/mL and CD4
count >200 cells/mm3
within the past 6
months, Please
confirm the subject has
been on stable
antiretroviral therapy
for at least 6 months
(Protocol 10.8).
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841713
Page 150 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-21-2020 17:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
human immunodeficiency virus
diseaseInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-21-2020 17:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-21-2020 17:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-21-2020 17:03:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:cesarean secti
on
Start Date: Nov/11/1974
Ongoing: NO
End Date:
Nov/11/19
74Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841714
Page 151 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:03:30
(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
Sep-21-2020 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cesarean sectionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-21-2020 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Nov/11/1974Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-21-2020 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Nov/11/1974Initial Entry
1.c
Date Location User Value Reason
Sep-21-2020 17:11:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:newborn deliv
ery
Start Date: Nov/11/1974
Ongoing: NO
End Date:
Nov/11/197
4Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841715
Page 152 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:11:21
(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
Sep-21-2020 17:11:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
newborn deliveryInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-21-2020 17:11:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Nov/11/1974Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-21-2020 17:11:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Nov/11/1974Initial Entry
1.d
Date Location User Value Reason
Sep-21-2020 17:12:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:cesarean secti
on
Start Date: Dec/20/1983
Ongoing: NO
End Date:
Dec/20/19
83Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841716
Page 153 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:12:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cesarean sectionInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-21-2020 17:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/20/1983Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-21-2020 17:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Dec/20/1983Initial Entry
1.e
Date Location User Value Reason
Sep-21-2020 17:12:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:newborn deliv
ery
Start Date: Dec/20/1983
Ongoing: NO
End Date:
Dec/20/198
3Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841717
Page 154 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.e Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:12:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
newborn deliveryInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-21-2020 17:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/20/1983Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-21-2020 17:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Dec/20/1983Initial Entry
1.f
Date Location User Value Reason
Sep-21-2020 17:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:cesarean secti
on
Start Date: Dec/31/1987
Ongoing: NO
End Date:
Dec/31/19
87Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841718
Page 155 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cesarean sectionInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-21-2020 17:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/31/1987Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-21-2020 17:14:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Dec/31/1987Initial Entry
1.g
Date Location User Value Reason
Sep-21-2020 17:14:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Te
rm:newborn deliv
ery
Start Date: Dec/31/1987
Ongoing: NO
End Date:
Dec/31/198
7Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841719
Page 156 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.g Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:14:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:14:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
newborn deliveryInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-21-2020 17:14:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/31/1987Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-21-2020 17:14:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Dec/31/1987Initial Entry
1.h
Date Location User Value Reason
Sep-21-2020 17:15:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:cesarean secti
on
Start Date: Oct/8/1991
Ongoing: NO
End Date:
Oct/8/1991Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841720
Page 157 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.h Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:15:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cesarean sectionInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-21-2020 17:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/8/1991Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-21-2020 17:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Oct/8/1991Initial Entry
1.i
Date Location User Value Reason
Sep-21-2020 17:16:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:newborn deliv
ery
Start Date: Oct/8/1991
Ongoing: NO
End Date:
Oct/8/1991Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841721
Page 158 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.i Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:16:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
newborn deliveryInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-21-2020 17:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/8/1991Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-21-2020 17:16:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NO
End Date:
Oct/8/1991Initial Entry
1.j
Date Location User Value Reason
Sep-21-2020 17:18:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Term
:anemia
Start Date: Dec/5/201
5
Ongoing: YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841722
Page 159 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:18:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 15:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-23-2020 10:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarQuery 1: Answered No blood products
received.
Sep-22-2020 20:12:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Anemia
reported: Please
confirm if subject
has received any
blood products in the
past 60 days for this
medhx.
Sep-21-2020 17:18:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
anemiaInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-21-2020 17:18:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/5/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-21-2020 17:18:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.k
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841723
Page 160 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-21-2020 17:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:hyperlipidem
ia
Start Date: Dec/5/2015
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:18:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
hyperlipidemiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-21-2020 17:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Dec/5/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-21-2020 17:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Sep-21-2020 17:19:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Term
:asthmaInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841724
Page 161 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: Jan/31/201
8
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:19:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
asthmaInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-21-2020 17:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Jan/31/2018Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-21-2020 17:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Sep-21-2020 17:21:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:chronic low bac
k pain
Start Date: Oct/8/2019
Ongoing: YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841725
Page 162 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.m Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:21:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
chronic low back painInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-21-2020 17:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/8/2019Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-21-2020 17:21:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Sep-21-2020 17:22:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Histo
ry Term:Gastroesophageal re
flux disease
Start Date: May/10/2017
Ongoing: YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841726
Page 163 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.n Line/MH Number:
Date Location User Value Reason
Sep-21-2020 17:22:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Gastroesophageal reflux diseaseInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-21-2020 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
May/10/2017Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-21-2020 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Nov-11-2020 13:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Te
rm:RHINITIS
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841727
Page 164 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.o Line/MH Number:
Date Location User Value Reason
Nov-11-2020 13:19:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-11-2020 13:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
RHINITISInitial Entry
1.o Start Date:
Date Location User Value Reason
Nov-11-2020 13:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
UNK/UNK/2018Initial Entry
1.o Ongoing:
Date Location User Value Reason
Nov-11-2020 13:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841728
Page 165 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-10-2020 02:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed As per site
confirmation - updated
PD tracker
Nov-09-2020 15:25:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered YES, YOU ARE
CORRECT. DOSE 2
VACCINE
REACTOGENICITY
WAS NOT
ACTIVATED AT
VISIT 2. STAFF
MEMBER IS AWARE
AND HAS BEEN
RETRAINED ON
THIS PD.
Nov-09-2020 05:16:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened PDQ : Response to
What is the subject
HIV status? is "The
subject is known to be
HIV POSITIVE",
however eDairy data is
missing for this
subject for Vaccination
2. Please review and
update if the diary data
is available else
provide a clarification.
Sep-24-2020 18:20:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-23-2020 16:36:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered UPDATED
Sep-22-2020 20:11:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Since
subject is known to be
HIV Positive, please
complete the HIV
RNA and CD4 CRFs
as per Protocol Sec
10.8
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0841729
Page 166 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-21-2020 17:03:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
The subject is known to be HIV
POSITIVEInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841730
Page 167 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
QUEST DIAGNOSTICS-MIAMI
, 10200 COMMERCE PARKWA
Y, MIRAMAR, FL 33025-3938 L
aboratory Director: JULIE L FRI
EDMAN,MD, CLIA: 10D027733
4Initial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:2124
Test:: HIV RNA (Ultra
sensitive)
Result:: NOT DETECTE
DInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841731
Page 168 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Normal Ran
ge:High
<20
Unit
/mL
5.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2124Initial Entry
5.a Test:
Date Location User Value Reason
Sep-23-2020 16:34:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HIV RNA (Ultrasensitive)Initial Entry
5.a Result:
Date Location User Value Reason
Oct-17-2020
07:33:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Cl
osedAs per site
response
Oct-16-2020
14:59:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 2: An
sweredVALUE
READS "NOT
DETECTED"
PLEASE
CHECK WITH
SOURCE IN
FLORENCE.
THANK YOU.
Oct-14-2020
06:29:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 2: Op
enedLab Result is
not valid and
should be a
numeric value.
Please review
and update as
necessary based
on the
Reference
090177e196ae30bc\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-2021-5683-0841732
Page 169 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Range provided
in the Lab
Records (please
ensure no
commas or
ranges).
Sep-24-2020
01:58:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Cl
osedResponse
satisfies query
Sep-23-2020
16:34:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredOriginal value
is correct
Sep-23-2020
16:34:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Op
enedResult is
present, but lab
normal range
(Low, high or
Unit) is
missing. Please
correct or
confirm.
Sep-23-2020
16:34:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DETE
CTEDInitial Entry
5.a LNMT
Date Location User Value Reason
Sep-26-2020 04:24:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site response
Sep-25-2020 14:13:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered based on the medical
records, subjects
HIV 1 RNA, QN
PCR results are <20
NOT DETECTED.
Thus, <20 would be
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841733
Page 170 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
the low normal
range. Is this what
you require?
Sep-25-2020 01:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Kindly review
and update 'Low
normal range' as per
completion
requirement section
8.22.5. Else please
clarify.
Sep-24-2020 14:05:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Query 1: Answered Original value is
correct
Sep-24-2020 01:58:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Result is present, but
lab normal range
(Low) is missing.
Please correct or
confirm.
Sep-23-2020 16:34:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
High
<20
Unit
/mLInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841734
Page 171 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 16:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Sep-23-2020 16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
QUEST DIAGNOSTICS-MIAMI
, 10200 COMMERCE PARKWA
Y, MIRAMAR, FL 33025-3938 L
aboratory Director: JULIE L FRI
EDMAN,MD, CLIA: 10D027733
4Initial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Sep-23-2020 16:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Nov-13-2020 16:24:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:4722
Test:: CD4_PX4
722
Result:: 1.102Changed
Information
090177e196ae30bc\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-2021-5683-0841735
Page 172 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Normal Range: Low
0.49
High
1.74
Unit
10^3/m
m3
Nov-13-2020 16:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:4722
Test:: CD4_PX4
722
Result:: 1.102
Lab Normal Range: Low
490
High
1740
Unit
10^3/m
m3Changed
Information
Sep-23-2020 16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:4722
Test:: CD4_PX4
722
Result:: 1102
Lab Normal Range: Low
490
High
1740
Unit
10^3/m
m3Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841736
Page 173 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-23-2020 16:36:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4722Initial Entry
5.a Test:
Date Location User Value Reason
Sep-23-2020 16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CD4_PX4722Initial Entry
5.a Result:
Date Location User Value Reason
Nov-16-2020 02:53:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Nov-13-2020 16:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Nov-13-2020 16:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1.102Changed
Information
Nov-12-2020 21:36:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Please enter
the CD4 absolute
values only, LNMT
Low and LNMT
High, after dividing
the number by 1000
to allow using the
Unit provided
“10^3/mm3”
equivalent to
“1000/mm3”
Sep-23-2020 16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1102Initial Entry
5.a LNMT
Date Location User Value Reason
Nov-13-2020 16:24:22
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LowChanged
Information
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841737
Page 174 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada) 0.49
High
1.74
Unit
10^3/mm3
Sep-23-2020 16:36:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
490
High
1740
Unit
10^3/mm3Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0841738
Page 175 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
73.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
143.7Initial Entry
5. Unit:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.4Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841739
Page 176 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 17:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841740
Page 177 of 246
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
Aguilar
(Data Entry:
Sponsor-Defined Ide
ntifier:Not Applic
ableInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841741
Page 178 of 246
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-21-2020 17:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841742
Page 179 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-21-2020 17:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sep/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-21-2020 17:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
261932Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841743
Page 180 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 17:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 17:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 17:47:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 17:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-21-2020 17:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020 17:47:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHS77Initial Entry
5.a Sample ID
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841744
Page 181 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-21-2020 17:47:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHS77Initial Entry
5.b
Date Location User Value Reason
Sep-21-2020 17:47:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BPHS78Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-21-2020 17:47:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BPHS78Initial Entry
5.c
Date Location User Value Reason
Sep-21-2020 17:47:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP18NGInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-21-2020 17:47:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18NGInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841745
Page 182 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 17:43:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 17:43:08
(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-21-2020 17:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 17:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-21-2020 17:43:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-21-2020 17:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BP18NLInitial Entry
5.a Sample ID
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841746
Page 183 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-21-2020 17:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BP18NLInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841747
Page 184 of 246
***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: 11561160 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-21-2020 17:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 17:25:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 17:25:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-19-2020 05:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation
Oct-16-2020 09:53:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered EDIARY WAS NOT
ABLE TO BE
ACTIVATED
UNTIL 9/25.
VACCINE WAS
GIVEN 9/21
Oct-14-2020 04:38:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per eDiary
records, vaccination
date is 25-Sep-2020.
Please reconcile or
confirm in the query
response as
appropriate.
Sep-21-2020 17:25:20 ACV0PFEINFP6000  Hector Aguilar Data Entry: Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841748
Page 185 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)Sep/21/2020 14:06
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 17:25:20
(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-21-2020 17:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020 17:25:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-21-2020 17:25:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-21-2020 17:25:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841749
Page 186 of 246
***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: 11561160 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
Sep-23-2020 16:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTNew Information
Sep-21-2020 17:25:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841750
Page 187 of 246
***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: 11561160 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-13-2020 11:51:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/12/2020Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841751
Page 188 of 246
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: FAT
IG
UEInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841752
Page 189 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841753
Page 190 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: CH
IL
LS
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841754
Page 191 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841755
Page 192 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2.h
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841756
Page 193 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841757
Page 194 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:NOInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841758
Page 195 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-13-2020 12:03:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841759
Page 196 of 246
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-13-2020 11:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/12/2020Initial Entry
2.a
Date Location User Value Reason
Oct-13-2020 11:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-13-2020 11:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-13-2020 11:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-13-2020 11:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841760
Page 197 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-13-2020 11:56:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
ORAL CAVITYInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841761
Page 198 of 246
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sponsor-Defined Ide
ntifier:Not Applic
ableInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841762
Page 199 of 246
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-13-2020 11:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841763
Page 200 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 12:23:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 12:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 12:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-13-2020 12:23:15
(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-13-2020 12:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Sample ID: BR2Z1SInitial Entry
5.a Sample ID
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841764
Page 201 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-13-2020 12:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
BR2Z1SInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841765
Page 202 of 246
***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: 11561160 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
Oct-13-2020 11:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Oct/12/2020 15:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
LEFTInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841766
Page 203 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-13-2020 11:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
YESInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841767
Page 204 of 246
***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: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 16:00:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Nov/10/2020Initial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841768
Page 205 of 246
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-11-2020
18:50:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_FAVSD011_01
Nov-11-2020
14:40:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
AnsweredChanged data per
query
Nov-11-2020
14:40:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
Not DoneInitial Entry
Nov-11-2020
03:32:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW5346236;Were
medications to treat
fever/pain
given on the last day
the Subject
Diary was
completed? is not
expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or
clarify
Nov-10-2020
16:01:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data Ent
ry:
Not Appli
cableInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841769
Page 206 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a
Date Location User Value Reason
Nov-11-2020 14:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Don
eInitial Entry
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Appl
icabl
eInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-11-2020
18:50:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check:
VC_FAVSD011_02
Nov-11-2020
14:40:59
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841770
Page 207 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Canada)
Nov-11-2020
14:40:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
Nov-11-2020
03:35:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5346160;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-10-2020
16:01:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data
Entry
:
Not A
pplica
bleInitial Entry
2.b
Date Location User Value Reason
Nov-11-2020 14:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Don
eInitial Entry
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Appl
icabl
eInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841771
Page 208 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.b Symptom:
Date Location User Value Reason
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-11-2020
18:50:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check:
VC_FAVSD011_02
Nov-11-2020
14:41:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
Nov-11-2020
14:40:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
Nov-11-2020
03:35:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5346161;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-10-2020
16:01:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data
Entry
:
Not A
pplica
bleInitial Entry
2.c
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841772
Page 209 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-11-2020 14:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Don
eInitial Entry
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Appl
icabl
eInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841773
Page 210 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-11-2020
18:50:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check:
VC_FAVSD011_02
Nov-11-2020
14:41:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
Nov-11-2020
14:40:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
Nov-11-2020
03:35:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5346162;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-10-2020
16:01:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data
Entry
:
Not A
pplica
bleInitial Entry
2.d
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841774
Page 211 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-11-2020 14:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Don
eInitial Entry
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Appl
icabl
eInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841775
Page 212 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.d Symptom:
Date Location User Value Reason
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-11-2020
18:50:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check:
VC_FAVSD011_02
Nov-11-2020
14:47:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
Nov-11-2020
14:40:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
Nov-11-2020
03:35:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5346163;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-10-2020
16:01:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data
Entry
:
Not A
pplica
bleInitial Entry
2.e
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841776
Page 213 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-11-2020 14:40:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Don
eInitial Entry
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector Aguilar Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:Not
Appl
icabl
eInitial Entry
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841777
Page 214 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1156 Site Name: (1156) Acevedo Clinical Research Associates
Subject No: 11561160 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.e Symptom:
Date Location User Value Reason
Nov-10-2020 16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hector
AguilarData Entry:
Not ApplicableInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User ValueReason
Nov-11-2020
18:50:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check:
VC_FAVSD011_02
Nov-11-2020
14:47:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredChanged data per query
Nov-11-2020
14:40:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not D
oneInitial Entry
Nov-11-2020
03:35:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5346164;Symptoms
Occur? is not expected to
be Unknown or Not
Applicable. Please review
and update appropriately
or clarify
Nov-10-2020
16:01:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hector Aguilar Data
Entry
:
Not A
pplica
bleInitial Entry
2.f
090177e196ae30bc\Final\Final On: 01-Apr-2021 04:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0841778
Page 215 of 246
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Ve
…[truncated]
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CURRICULUM VITAE Ryan C. W. Hall, M.D., DFAPA Updated 10/11/21 EXHIBIT D EFTA00073117 TABLE OF CONTENTS PRESENT POSITION 2 EDUCATION 2 MEDICAL LICENSE 3 CERTIFICATION 3 ADDITIONAL TRAINING 3 SOCIETY MEMBERSHIPS. PAST AND…
Federal Writers' Project

[Mining Lore of Waldo]
WPI L. C. PROJE'CT UNIT e-Ife ,:f-S Accession n3. W 9.0 Date received /y 0 Consignment no. Shipped from Label Amount AA. Form -3 0.%Lee(7,e. Collection (or Type) Title.. Place of origin Date atel Project worker e Project…
[Forgotten Chapter in Lafayette's Civil War]
!nit )s Accession no. u-stom s- k-k.\1ch.A9. WPA L. C. PROJECT Form -3 -Arall1.4) UNIT 12643 Date received /0//0 fahie) Consignent no. Shipped from &di). Label Amount 43-fv. Collection (or Type) Place of originLiZ ng/• D…
[Early Portland Folkways]
Pee -Ors 4"J er,i7vAls -retA",10**ErS, Amnion no. WPA L. C. PROJECT UNIT Form -3 /J-F'd Date received 47, Consignment no. Shipped from Label AV:al-4 514 Amount olv Collection (or Type) Title Date...11,4/ Place of origin …
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