Document text
Page 1 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877803
Page 2 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877804
Page 3 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Demography
1.Subject ID [12313755]
2.Birth Date: /1949
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877805
Page 4 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877806
Page 5 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877807
Page 6 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877808
Page 7 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877809
Page 8 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877810
Page 9 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877811
Page 10 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast Cancer]
Start Date: Mar/1/2012
Ongoing: NO
End Date:
Mar/1/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arterial Hypertension]
Start Date: Jan/1/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acoustic Neuroma]
Start Date: Nov/1/2013
Ongoing: NO
End Date:
Feb/1/2014
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Palpitations]
Start Date: Jan/1/2008
Ongoing: YES
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877812
Page 11 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [82.55]
3.Unit: kg
4.Height: [161.0]
5.Unit: cm
6.Body Mass Index: [31.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877813
Page 12 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877814
Page 13 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [239121]
3.Randomization Group: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877815
Page 14 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BP2DP3]
5.bSample ID [BP2DP4]
5.cSample ID [BP2DP5]
5.dSample ID [BNTYM0]
5.eSample ID [BNTYM1]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877816
Page 15 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BNTYM0 ]
5.bSample ID [BNTYM1 ]
5.cSample ID [BP24NT]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877817
Page 16 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/24/2020 20:45
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
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877818
Page 17 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877819
Page 18 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877820
Page 19 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877821
Page 20 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877822
Page 21 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1R91]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877823
Page 22 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/15/2020 12:48
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
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877824
Page 23 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877825
Page 24 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBKM2]
5.bSample ID [BLBKMK]
5.cSample ID [BP1PKL]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877826
Page 25 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877827
Page 26 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877828
Page 27 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877829
Page 28 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877830
Page 29 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877831
Page 30 of 228
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877832
Page 31 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877833
Page 32 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877834
Page 33 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877835
Page 34 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Unplanned Assessments
1.Assessments
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877836
Page 35 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877837
Page 36 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877838
Page 37 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877839
Page 38 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877840
Page 39 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 right peripheral facial he
miparesis Oct/16/2020 0
8:00 NO
End Date Time:
Oct/30/2020 20:00
Repeating
Pages
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877841
Page 40 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[right peripheral facial hemiparesis]
4.Start Date Time: Oct/16/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/30/2020 20:00
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:
[Unknown]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877842
Page 41 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877843
Page 42 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877844
Page 43 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877845
Page 44 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877846
Page 45 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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: //
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877847
Page 46 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877848
Page 47 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877849
Page 48 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877850
Page 49 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877851
Page 50 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877852
Page 51 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877853
Page 52 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877854
Page 53 of 228
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877855
Page 54 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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:
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877856
Page 55 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877857
Page 56 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877858
Page 57 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877859
Page 58 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/17/2021
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877860
Page 59 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877861
Page 60 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/17/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877862
Page 61 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877863
Page 62 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877864
Page 63 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877865
Page 64 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/21/2021
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877866
Page 65 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877867
Page 66 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877868
Page 67 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877869
Page 68 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BRZ4GX]
5.bSample ID [BRZ4FD]
5.cSample ID [BPWF8L]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877870
Page 69 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [BPWBM9]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877871
Page 70 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/21/2021 14:25
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
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877872
Page 71 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877873
Page 72 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877874
Page 73 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
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 [BHXH7F]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877875
Page 74 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/12/2021 14:51
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
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877876
Page 75 of 228
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877877
Page 76 of 228
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/12/2021
3.Comments: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877878
Page 77 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877879
Page 78 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877880
Page 79 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877881
Page 80 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877882
Page 81 of 228
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/12/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877883
Page 82 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877884
Page 83 of 228
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877885
Page 84 of 228
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877886
Page 85 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormAug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877887
Page 86 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Aug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877888
Page 87 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Aug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877889
Page 88 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Aug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877890
Page 89 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Aug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877891
Page 90 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Aug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877892
Page 91 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aAug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877893
Page 92 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aAug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877894
Page 93 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aAug-25-2020 09:10:35 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877895
Page 94 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormSep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877896
Page 95 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Sep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877897
Page 96 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Sep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877898
Page 97 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Sep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877899
Page 98 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Sep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877900
Page 99 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Sep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877901
Page 100 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aSep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877902
Page 101 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aSep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877903
Page 102 of 228
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aSep-16-2020 08:36:56 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877904
Page 103 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormJan-21-2021 15:13:07 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877905
Page 104 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormJan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877906
Page 105 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Jan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877907
Page 106 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Jan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877908
Page 107 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Jan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877909
Page 108 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Jan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877910
Page 109 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Jan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877911
Page 110 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aJan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877912
Page 111 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aJan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877913
Page 112 of 228
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aJan-21-2021 15:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877914
Page 113 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormFeb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877915
Page 114 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Feb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877916
Page 115 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Feb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877917
Page 116 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Feb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877918
Page 117 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Feb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877919
Page 118 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Feb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877920
Page 119 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aFeb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877921
Page 120 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aFeb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877922
Page 121 of 228
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aFeb-12-2021 17:02:00 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877923
Page 122 of 228
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-12-2021 11:26:16 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-17-2021 11:16:16 (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.
Agustin Morato
Cabral N/A Feb-10-2021 16:58:16 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 15:42:37 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b)
(6)
(b) (6)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0877924
Page 123 of 228
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 Jan-21-2021 15:11:55 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta Approved Jan-21-2021 12:41:47 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, 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 Jan-17-2021 18:54:20 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-05-2020 21:39:59 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877925
Page 124 of 228
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Affidavit:
By my dated signature below, I, FernandoPolack, 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-05-2020 14:19:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 22:56:36 (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.
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877926
Page 125 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020 09:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020 09:05:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877927
Page 126 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 09:06:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877928
Page 127 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 20:14:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12313755Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 20:14:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 09:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 09:06:26
(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-25-2020 09:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877929
Page 128 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 09:06:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877930
Page 129 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclus
ive, at randomization (de
pendent upon study stage
)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, incInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877931
Page 130 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
lusive, 65 and 85 years, inclusive,
or 18 and 85 years, inclusive, at ra
ndomization (dependent upon stu
dy stage)
1.a Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are will
ing and able to comply w
ith all scheduled visits, v
accination plan, laborator
y tests, lifestyle consider
ations, and other study pr
ocedures
Criteri
on met
?:YESInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877932
Page 131 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criteri
on ID:
(For P
fizer u
se only
):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and a
ble to comply with all scheduled v
isits, vaccination plan, laboratory
tests, lifestyle considerations, and
other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877933
Page 132 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criter
ion De
scripti
on:Healthy participants who
are determined by medic
al history, physical exami
nation, and clinical judg
ment of the investigator t
o be eligible for inclusio
n in the study
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877934
Page 133 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.c Inclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are deter
mined by medical history, physica
l examination, and clinical judgm
ent of the investigator to be eligibl
e for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877935
Page 134 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compl
iance with the requireme
nts and restrictions listed
in the ICD and in this pr
otocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877936
Page 135 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.d Inclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion N
umber
:1Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877937
Page 136 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criter
ion De
scripti
on:Other medical or psychia
tric condition incl. recent
(within past year) or activ
e suicidal ideation/behavi
or/lab abnormality that m
ay increase the risk of stu
dy participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric cond
ition incl. recent (within past year
) or active suicidal ideation/behav
ior/lab abnormality that may incre
ase the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877938
Page 137 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepa
titis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877939
Page 138 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.b Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human im
munodeficiency virus (HIV), hepa
titis C virus (HCV), or hepatitis B
virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877940
Page 139 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criteri
on Des
criptio
n:History of severe advers
e reaction associated wit
h a vaccine and/or severe
allergic reaction (eg, ana
phylaxis) to any compon
ent of the study intervent
ion(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877941
Page 140 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.c Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction
associated with a vaccine and/or s
evere allergic reaction (eg, anaphy
laxis) to any component of the stu
dy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877942
Page 141 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended t
o prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu8Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877943
Page 142 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
mber:
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodefici
ency, as determined by h
istory and/or laboratory/
physical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877944
Page 143 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.e Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histo
ry and/or laboratory/physical exa
minationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877945
Page 144 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pr
olonged bleeding that wo
uld, in the opinion of the
investigator, contraindica
te intramuscular injectio
n
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877946
Page 145 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.f Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition as
sociated with prolonged bleeding
that would, in the opinion of the i
nvestigator, contraindicate intram
uscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or breas
tfeedingInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877947
Page 146 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breas
tfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877948
Page 147 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criterion De
scription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877949
Page 148 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic cort
icosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877950
Page 149 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.i Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxi
c agents or systemic corticosteroi
dsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877951
Page 150 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days befor
e study intervention adm
inistration or planned rec
eipt throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877952
Page 151 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.j Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention administ
ration or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877953
Page 152 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
2.k
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study in
tervention within 28 da
ys prior to study entry a
nd/or during study parti
cipation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877954
Page 153 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.k Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies invo
lving study intervention within 28
days prior to study entry and/or d
uring study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877955
Page 154 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Criterio
n Descri
ption:Previous participation
in other studies involv
ing study intervention
containing lipid nanop
articles
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other stu
dies involving study intervention
containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877956
Page 155 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.m
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or
Pfizer employees directly
involved in the conduct o
f the study, site staff othe
rwise supervised by the i
nvestigator, and their res
pective family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877957
Page 156 of 228
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.m Exclusion Number:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer em
ployees directly involved in the c
onduct of the study, site staff othe
rwise supervised by the investigat
or, and their respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-25-2020 09:06:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877958
Page 157 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020 09:07:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 09:07:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 09:07:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877959
Page 158 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 09:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Breast Cance
r
Start Date: Mar/1/2012
Ongoing: NO
End Date:
Mar/1/20
17Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 09:07:31
(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
Aug-25-2020 09:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Breast CancerInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 09:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/1/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877960
Page 159 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-25-2020 09:07:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/1/2017Initial Entry
1.b
Date Location User Value Reason
Aug-25-2020 09:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Arterial Hypert
ension
Start Date: Jan/1/2015
Ongoing: YESInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877961
Page 160 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 09:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 09:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Arterial HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 09:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/1/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020 09:07:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-25-2020 09:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Acoustic Neur
oma
Start Date: Nov/1/2013
Ongoing: NO
End Date:
Feb/1/2014Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877962
Page 161 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020 09:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 09:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Acoustic NeuromaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 09:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/1/2013Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020 09:08:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/1/2014Initial Entry
1.d
Date Location User Value Reason
Aug-25-2020 09:09:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Palpitation
s
Start Date: Jan/1/2008
Ongoing: YESInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877963
Page 162 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020 09:09:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 09:09:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PalpitationsInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 09:09:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/1/2008Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 09:09:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877964
Page 163 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
82.55Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
161.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877965
Page 164 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.8Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.4
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 09:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 09:10:09 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0877966
Page 165 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-03:00) City of
Buenos AiresORAL CAVITY
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877967
Page 166 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877968
Page 167 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-25-2020 09:10:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877969
Page 168 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 09:10:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 09:10:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
239121Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877970
Page 169 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 09:11:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 09:11:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 11:28:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 09:59:35
(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.
Aug-25-2020 09:11:03
(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-25-2020 09:11:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877971
Page 170 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Aug-26-2020 11:28:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP2DP3Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 11:28:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP2DP3Initial Entry
5.b
Date Location User Value Reason
Aug-26-2020 11:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP2DP4Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 11:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP2DP4Initial Entry
5.c
Date Location User Value Reason
Aug-26-2020 11:29:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP2DP5Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 11:29:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP2DP5Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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)
FDA-CBER-2021-5683-0877972
Page 171 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.d
Date Location User Value Reason
Aug-26-2020 14:50:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTYM0Initial Entry
5.d Sample ID
Date Location User ValueReason
Sep-08-2020
16:51:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Sep-08-2020
13:59:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Sep-07-2020
15:57:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4630041;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Aug-26-2020
14:50:30
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data
Entry
:
BNT
YM0Initial Entry
5.e
Date Location User Value Reason
Aug-26-2020 14:50:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BNTYM1Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877973
Page 172 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.e Sample ID
Date Location User ValueReason
Sep-08-2020
16:51:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Sep-08-2020
14:00:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: An
swere
dOriginal value is
correct
Sep-07-2020
15:57:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4630042;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Aug-26-2020
14:50:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data
Entry
:
BNT
YM1Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877974
Page 173 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 09:11:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 09:11:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 13:54:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Sep-08-2020 13:53:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 13:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-07-2020 11:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened There are more
than 1 barcode
present for sample
collection. Please
review and correct
as appropriate.
Sep-07-2020 11:38:11
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0877975
Page 174 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Buenos Aires
Aug-25-2020 09:59:35
(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.
Aug-25-2020 09:11:11
(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-25-2020 09:11:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 13:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTYM0Transcription Error
(DELETED)
Sep-07-2020 11:38:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTYM0Transcription Error
Sep-07-2020 11:38:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: bntym0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
04:08:20
(UTC-03:00)
City ofACV0PFEINFP6000 Query
2: Clos
edResponse satisfies
query
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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)
FDA-CBER-2021-5683-0877976
Page 175 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Buenos Aires
Sep-08-2020
13:53:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
BNTY
M0Transcription Error
(DELETED)
Sep-08-2020
13:53:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredTranscription Error
Sep-07-2020
15:57:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
2: Ope
nedDMW4630063;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Sep-07-2020
11:38:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Clos
edClose Auto Query
Sep-07-2020
11:38:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
BNTY
M0Transcription Error
Sep-07-2020
11:38:11
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Ope
nedBarcode contains
lower case letters
which is not the
correct format.
Please review and
correct as
appropriate.
Sep-07-2020
11:38:11
(UTC-03:00)
City ofACV0PFEINFP6000 Data E
ntry:
bntym0Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877977
Page 176 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Buenos Aires
5.b
Date Location User Value Reason
Sep-08-2020 13:53:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTYM1Transcription Error
(DELETED)
Sep-07-2020 11:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTYM1Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0877978
Page 177 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.b Sample ID
Date Location User Value Reason
Sep-09-2020
04:11:20
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
1: Clos
edData updated
Sep-08-2020
13:53:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
BNTY
M1Transcription Error
(DELETED)
Sep-08-2020
13:53:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-07-2020
15:57:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Ope
nedDMW4630064;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update
as appropriate.
Sep-07-2020
11:38:55
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data E
ntry:
BNTY
M1Initial Entry
5.c
Date Location User Value Reason
Sep-08-2020 13:54:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24NTInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0877979
Page 178 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Sample ID
Date Location User Value Reason
Sep-08-2020 13:54:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP24NTInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877980
Page 179 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/24/2020 20:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877981
Page 180 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 09:11:22
(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-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-25-2020 09:11:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877982
Page 181 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020 09:11:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877983
Page 182 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020 08:36:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877984
Page 183 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 08:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 08:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.6
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 08:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-16-2020 08:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020 08:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877985
Page 184 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 08:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877986
Page 185 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877987
Page 186 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-16-2020 08:36:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877988
Page 187 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 08:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 08:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 10:14:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-16-2020 08:52:26
(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.
Sep-16-2020 08:37:08
(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-16-2020 08:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877989
Page 188 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Sep-16-2020 10:14:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1R91Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 10:14:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1R91Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877990
Page 189 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/15/2020 12:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877991
Page 190 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 08:37:17
(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-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-16-2020 08:37:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877992
Page 191 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 13:27:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877993
Page 192 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020 13:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020 13:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 14:37:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-19-2020 13:27:46
(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.
Oct-19-2020 13:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020 14:37:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLBKM2Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877994
Page 193 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 14:37:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLBKM2Initial Entry
5.b
Date Location User Value Reason
Oct-19-2020 15:43:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLBKMKInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 15:43:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLBKMKInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 16:39:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1PKLInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 16:39:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1PKLInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877995
Page 194 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020 12:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 12:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 12:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0877996
Page 195 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0877997
Page 196 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 13:24:26
(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
Oct-23-2020 11:00:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Will follow-up with
site once MRI
results are received.
Oct-22-2020 19:44:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered A magnetic
resonance imaging
of the facial
acoustic package
and brain with
contrast was
performed, pending
results. Surveillance
follow-up is
requested. thank
you
Oct-22-2020 10:33:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-21-2020 19:04:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The AE is
continuous
Oct-20-2020 13:30:30 ACV0PFEINFP6000 Query 2: Opened ClinQuery: Please
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0877998
Page 197 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-03:00) City of
Buenos Airesconsidered
CAUSALITY. Is
the causality known
(e.g. TIA, CVA,
viral infection,
rickettsial
infection)?”
Oct-20-2020 13:09:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
confirm if AE is
continuous or
intermittent.
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
right peripheral facial hemipar
esisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/16/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-05-2020 14:19:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-05-2020 14:19:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/30/2020 20:00Transcription Error
Nov-05-2020 14:19:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For right peripheral
facial hemiparesis
End Date & Time
30/Sep/2020 20:00
is before the Start
Date & Time
16/Oct/2020 08:00.
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0877999
Page 198 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Nov-05-2020 14:19:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/30/2020 20:00New Information
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-23-2020 10:57:16
(UTC-03:00) City ofACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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)
FDA-CBER-2021-5683-0878000
Page 199 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Buenos Aires
Oct-22-2020 19:49:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered A magnetic
resonance imaging
of the facial
acoustic package
and brain with
contrast was
performed, pending
results.
Surveillance
follow-up is
requested. thank
you
Oct-20-2020 13:10:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened ClinQuery: Please
confirm if subject
has past medical
history for
hemiparesis. If yes,
please update
Medical History
record.
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0878001
Page 200 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-05-2020 14:19:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-05-2020 14:19:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-05-2020 14:19:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE right
peripheral facial
hemiparesis:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-19-2020 13:24:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 13:24:26
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (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-2021-5683-0878002
Page 201 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Buenos Aires
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0878003
Page 202 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-17-2021 18:54:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/17/2021Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878004
Page 203 of 228
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-17-2021 18:54:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-17-2021 18:54:26
(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-17-2021 18:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirme
d to have received only place
bo at Vaccination 1/2Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878005
Page 204 of 228
***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: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-17-2021 18:54:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/17/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-17-2021 18:54:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878006
Page 205 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021 15:11:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/21/2021Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878007
Page 206 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-21-2021 15:12:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtained
Jan/21/2021Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878008
Page 207 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-21-2021 15:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Jan/21/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-21-2021 15:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-21-2021 15:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878009
Page 208 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878010
Page 209 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Sponsor-Defined Id
entifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-21-2021 15:13:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Not ApplicableInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878011
Page 210 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 15:14:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 15:14:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 09:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-22-2021 07:29:12
(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-21-2021 15:14:23
(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-21-2021 15:14:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878012
Page 211 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Jan-22-2021 09:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ4GXInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021 09:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ4GXInitial Entry
5.b
Date Location User Value Reason
Jan-22-2021 13:50:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ4FDInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-22-2021 13:50:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ4FDInitial Entry
5.c
Date Location User Value Reason
Feb-10-2021 16:58:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BPWF8LInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878013
Page 212 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Sample ID
Date Location User Value Reason
Feb-10-2021 16:58:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BPWF8LInitial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878014
Page 213 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 15:14:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 15:14:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 11:31:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-22-2021 07:29:12
(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-21-2021 15:14:43
(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.
Jan-21-2021 15:14:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
090177e196d6f288\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b)
(6)
(
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0878015
Page 214 of 228
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313755 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Jan-22-2021 11:31:51
(UTC-03:00) City of
Buenos AiresAC
…[truncated]