125742 S1 M5 CRF c4591001 1231 12314813

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
160
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 160
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885730
Page 2 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885731
Page 3 of 160
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314813]
2.Birth Date: /1973
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885732
Page 4 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885733
Page 5 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885734
Page 6 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885735
Page 7 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[S1 disc extrusion and L4-L5 bulging]
Start Date: Oct/1/2000
Ongoing: YES
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885736
Page 8 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [68.0]
3.Unit: kg
4.Height: [178.0]
5.Unit: cm
6.Body Mass Index: [21.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885737
Page 9 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885738
Page 10 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [72154]
3.Randomization Group: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885739
Page 11 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJ4B3D]
5.bSample ID [BJ4B3F]
5.cSample ID [BJ4B3G]
5.dSample ID [BPWVY9]
5.eSample ID [BPWVYB]
5 fSample ID [BPWVYC]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885740
Page 12 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTDP5]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885741
Page 13 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 13:40
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
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885742
Page 14 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885743
Page 15 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885744
Page 16 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885745
Page 17 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885746
Page 18 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BPWB2P]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885747
Page 19 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/17/2020 14:20
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
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885748
Page 20 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885749
Page 21 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BJ4DT5]
5.bSample ID [BJ4DW3]
5.cSample ID [BP1P68]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885750
Page 22 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885751
Page 23 of 160
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885752
Page 24 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885753
Page 25 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885754
Page 26 of 160
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885755
Page 27 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885756
Page 28 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885757
Page 29 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885758
Page 30 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885759
Page 31 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885760
Page 32 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885761
Page 33 of 160
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885762
Page 34 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885763
Page 35 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885764
Page 36 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885765
Page 37 of 160
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885766
Page 38 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885767
Page 39 of 160
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885768
Page 40 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885769
Page 41 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885770
Page 42 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885771
Page 43 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885772
Page 44 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885773
Page 45 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/28/2021
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885774
Page 46 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885775
Page 47 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/28/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885776
Page 48 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/28/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885777
Page 49 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS4218]
5.bSample ID [BS4219]
5.cSample ID [BPWFHC]
5.dSample ID [BRYWHV]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885778
Page 50 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWFPM]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885779
Page 51 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 15:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885780
Page 52 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885781
Page 53 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/17/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885782
Page 54 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR286W]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885783
Page 55 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/17/2021 14:03
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885784
Page 56 of 160
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/18/2021
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885785
Page 57 of 160
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/18/2021
3.Comments: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885786
Page 58 of 160
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885787
Page 59 of 160
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885788
Page 60 of 160
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885789
Page 61 of 160
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885790
Page 62 of 160
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/18/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885791
Page 63 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Low back pain  Sep/21/2020 09:
00 NO
End Date Time:
Oct/12/2020 09:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Worsening of herniated
disc Sep/21/2020 09:
00 NO
End Date Time:
Jan/5/2021 17:00
 Repeating
Pages
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885792
Page 64 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[Low back pain]
4.Start Date Time: Sep/21/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/12/2020 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[disc extrusion at S1 and bulge at L4-L5]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885793
Page 65 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885794
Page 66 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of herniated disc]
4.Start Date Time: Sep/21/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/5/2021 17:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[history of herniated disc]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885795
Page 67 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020512052]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885796
Page 68 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885797
Page 69 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885798
Page 70 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885799
Page 71 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: //
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885800
Page 72 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885801
Page 73 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885802
Page 74 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885803
Page 75 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885804
Page 76 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885805
Page 77 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885806
Page 78 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885807
Page 79 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885808
Page 80 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885809
Page 81 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/11/2020
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885810
Page 82 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885811
Page 83 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-19-2021 13:53:47 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885812
Page 84 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-28-2020 16:07:42 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885813
Page 85 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormNov-12-2020 08:24:11 (UTC-03:00) City of Buenos
Aires
FormAug-28-2020 16:08:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885814
Page 86 of 160
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormJan-28-2021 15:48:44 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885815
Page 87 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-19-2021 13:53:47 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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 Mar-18-2021 10:48:59 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Tatiana Estrada  Approved Feb-19-2021 18:58:13 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, 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 Feb-18-2021 09:58:13 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-17-2021 21:50:22 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885816
Page 88 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I,  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.
Martina Davalli  N/A Feb-17-2021 15:38:46 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-29-2021 15:25:11 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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 Jan-28-2021 15:46:57 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 08:29:06 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) 
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885817
Page 89 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
 N/A Jan-02-2021 10:33:38 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 12:26:51 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  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-12-2020 11:08:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 09:33:48 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , 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.
Martina Davalli  N/A Nov-11-2020 16:11:28 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-06-2020 14:36:49 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885818
Page 90 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I,  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.
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885819
Page 91 of 160
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 16:07:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 16:07:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885820
Page 92 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 16:07:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885821
Page 93 of 160
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 14:45:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314813Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 14:45:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 16:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 16:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 16:07:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885822
Page 94 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 16:07:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885823
Page 95 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 16:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 16:07:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 16:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885824
Page 96 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Nov-12-2020 08:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:S1 disc extrusion and
L4-L5 bulging
Start Date: Oct/1/2000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-12-2020 08:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-12-2020 08:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
S1 disc extrusion and L4-L5 bulgingInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-12-2020 08:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/1/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-12-2020 08:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885825
Page 97 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
68.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
178.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.5Initial Entry
7.a
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885826
Page 98 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 16:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885827
Page 99 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885828
Page 100 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 16:08:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885829
Page 101 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 16:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 16:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
72154Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885830
Page 102 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 16:08:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 16:08:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 16:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 16:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-28-2020 16:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 16:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BJ4B3DInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885831
Page 103 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-29-2020 16:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ4B3DInitial Entry
5.b
Date Location User Value Reason
Aug-29-2020 16:37:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BJ4B3FInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-29-2020 16:37:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ4B3FInitial Entry
5.c
Date Location User Value Reason
Aug-29-2020 16:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BJ4B3GInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-29-2020 16:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ4B3GInitial Entry
5.d
Date Location User Value Reason
Aug-30-2020 11:31:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BPWVY9Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-30-2020 11:31:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPWVY9Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885832
Page 104 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.e
Date Location User Value Reason
Aug-30-2020 11:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BPWVYBInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-30-2020 11:31:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPWVYBInitial Entry
5.f
Date Location User Value Reason
Aug-30-2020 11:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BPWVYCInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-30-2020 11:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPWVYCInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885833
Page 105 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 16:08:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 16:08:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020 08:59:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 16:08:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-28-2020 16:08:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020 08:59:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTDP5Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885834
Page 106 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-30-2020 08:59:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTDP5Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885835
Page 107 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020 13:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885836
Page 108 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-28-2020 16:09:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885837
Page 109 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 16:09:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885838
Page 110 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 15:47:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885839
Page 111 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 15:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 15:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 15:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 15:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 15:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885840
Page 112 of 160
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-17-2020 15:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885841
Page 113 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885842
Page 114 of 160
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 15:47:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885843
Page 115 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 15:48:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 15:48:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 18:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 15:48:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-17-2020 15:48:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 18:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPWB2PInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885844
Page 116 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020 18:12:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPWB2PInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885845
Page 117 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020 14:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885846
Page 118 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7. Route:
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 15:48:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-17-2020 15:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885847
Page 119 of 160
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-12-2020
13:29:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-12-2020
09:00:47
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredThe visit was not carried out in
the corresponding time for
personal reasons of the
volunteer.
Nov-12-2020
06:34:23
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 20 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Nov-11-2020
17:58:07
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Nov/1
1/202
0Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
 
(b) (4)
FDA-CBER-2021-5683-0885848
Page 120 of 160
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 17:58:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 17:58:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020 19:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-11-2020 17:58:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-11-2020 17:58:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020 19:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BJ4DT5Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885849
Page 121 of 160
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-11-2020 19:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ4DT5Initial Entry
5.b
Date Location User Value Reason
Nov-12-2020 11:08:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ4DW3Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 11:08:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ4DW3Initial Entry
5.c
Date Location User Value Reason
Nov-12-2020 12:05:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1P68Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 12:05:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP1P68Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885850
Page 122 of 160
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020 17:58:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-11-2020 17:58:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020 17:58:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885851
Page 123 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 12:30:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/18/2021Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885852
Page 124 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021 12:30:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 12:30:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-19-2021 12:30:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible per local/national recomm
endations and confirmed to have r
eceived only placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885853
Page 125 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 15:46:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885854
Page 126 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-28-2021 15:47:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/28/2021Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885855
Page 127 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-28-2021 15:49:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-28-2021 15:49:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-28-2021 15:49:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885856
Page 128 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885857
Page 129 of 160
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-28-2021 15:49:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885858
Page 130 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 15:49:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 15:49:42
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 09:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-29-2021 05:15:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-28-2021 15:49:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-28-2021 15:49:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885859
Page 131 of 160
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Jan-29-2021 09:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS4218Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 09:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS4218Initial Entry
5.b
Date Location User Value Reason
Jan-29-2021 09:47:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS4219Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-29-2021 09:47:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS4219Initial Entry
5.c
Date Location User Value Reason
Jan-29-2021 13:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWFHCInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-29-2021 13:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWFHCInitial Entry
5.d
Date Location User Value Reason
Jan-29-2021 13:48:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRYWHVInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885860
Page 132 of 160
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sample ID
Date Location User Value Reason
Jan-29-2021 13:48:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRYWHVInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885861
Page 133 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 15:50:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 15:50:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 11:37:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-29-2021 05:15:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-28-2021 15:50:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-28-2021 15:50:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885862
Page 134 of 160
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Jan-29-2021 11:37:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWFPMInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 11:37:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWFPMInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885863
Page 135 of 160
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021 15:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885864
Page 136 of 160
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-28-2021 15:55:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885865
Page 137 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 15:38:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/17/2021Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885866
Page 138 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/17/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885867
Page 139 of 160
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-17-2021 15:39:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885868
Page 140 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 15:39:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 15:39:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021 09:58:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 09:47:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-17-2021 15:39:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-17-2021 15:39:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021 09:58:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR286WInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885869
Page 141 of 160
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Feb-18-2021 09:58:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR286WInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885870
Page 142 of 160
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/17/2021 14:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885871
Page 143 of 160
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-17-2021 15:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885872
Page 144 of 160
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-18-2021 10:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/18/2021Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885873
Page 145 of 160
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-18-2021 10:49:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-18-2021 10:49:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/18/2021Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885874
Page 146 of 160
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-18-2021 12:51:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-18-2021 12:51:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-18-2021 12:51:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885875
Page 147 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885876
Page 148 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885877
Page 149 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Low back painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/21/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO
End Date Time:
Oct/12/2020 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
2Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885878
Page 150 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
disc extrusion at S1 and bulge a
t L4-L5Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885879
Page 151 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 16:11:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885880
Page 152 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-26-2021 01:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-15-2021 17:36:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered A follow-up form for
the serious adverse
event is sent to the
sponsor, clarifying that
the date of knowledge
of the SAE is DEC 22,
2020.
Jan-13-2021 10:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened CLINICAL Thank
you; however most
recent SAE update
(10Jan21) did not
include any
medications (other
than VAX2) in the
Product Information
section of SAE report.
Jan-11-2021 10:07:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered SAE safety report was
sent with this
information.
Jan-08-2021 11:52:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical Please submit
a SAE safety report
reporting the subjects
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885881
Page 153 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
medications at time of
hosp admission in
Meds section (text has
tramadol,
acetaminophen,
pregabalin)
Jan-02-2021 10:33:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Worsening of herniated discInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/21/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-06-2021 11:08:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/5/2021 17:00New Information
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-12-2021 17:26:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Samuel
DychterQuery 1: Closed Response satisfies
query
Jan-08-2021 12:14:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Jan-08-2021 12:14:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
3Changed Information
Jan-06-2021 21:55:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Samuel
DychterQuery 1: Opened GPD Clin: Please
confirm Grade 4 for
this event.
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885882
Page 154 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Jan-02-2021 10:33:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-05-2021 08:43:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Worsening of
herniated disc:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Did this serious event result in persist
ent or significant disability/incapacity
?
NO
Is this serious event life threatening?Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885883
Page 155 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
NO
Other medically important serious ev
ent
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
history of herniated discInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885884
Page 156 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-06-2021 11:08:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-06-2021 11:08:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Jan-06-2021 11:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Worsening of
herniated disc:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Jan-02-2021 10:33:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-02-2021 10:33:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-05-2021 08:43:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2020512052Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885885
Page 157 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021 12:30:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021 12:30:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885886
Page 158 of 160
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-11-2020 17:58:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 16:08:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 16:07:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-05-2021 08:42:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies query
Jan-04-2021 16:30:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered SAE was loaded in AE
CRF.
Jan-02-2021 07:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020512052
Disc herniation
worsening(onset
date:21Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Nov-11-2020 17:58:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
Aug-28-2020 16:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020 16:07:56
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885887
Page 159 of 160
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885888
Page 160 of 160
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314813 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 14:36:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e65\Final\Final On: 01-Apr-2021 03:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885889
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