125742 S1 M5 CRF c4591001 1231 12312390

Document text

Page 1 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867243
Page 2 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867244
Page 3 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12312390]
2.Birth Date: /1995
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867245
Page 4 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867246
Page 5 of 208
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867247
Page 6 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867248
Page 7 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867249
Page 8 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867250
Page 9 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867251
Page 10 of 208
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [110.0]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [38.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867252
Page 11 of 208
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867253
Page 12 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [57348]
3.Randomization Group: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867254
Page 13 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHY501]
5.bSample ID [BHY502]
5.cSample ID [BHY503]
5.dSample ID [BJ527Z]
5.eSample ID [BJ5281]
5 fSample ID [BJ5280]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867255
Page 14 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHY4VD]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867256
Page 15 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 17:56
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
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867257
Page 16 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867258
Page 17 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867259
Page 18 of 208
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867260
Page 19 of 208
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/9/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867261
Page 20 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP1YSC]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867262
Page 21 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/9/2020 10:55
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
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867263
Page 22 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867264
Page 23 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BLDYYP]
5.bSample ID [BPW77W]
5.cSample ID [BLDYXT]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867265
Page 24 of 208
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867266
Page 25 of 208
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/9/2021
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 [BR1PKG]
5.bSample ID [BRYX9Z]
5.cSample ID [BRYX99]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867267
Page 26 of 208
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867268
Page 27 of 208
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867269
Page 28 of 208
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867270
Page 29 of 208
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867271
Page 30 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867272
Page 31 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/16/2020
2.Date of First Symptom Started: Sep/16/2020 Comments
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/18/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867273
Page 32 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867274
Page 33 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Sep/16/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867275
Page 34 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/16/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867276
Page 35 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[At visit 3, subject declares SWAB collected outside the study.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867277
Page 36 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample not collected] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867278
Page 37 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867279
Page 38 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867280
Page 39 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867281
Page 40 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867282
Page 41 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867283
Page 42 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867284
Page 43 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867285
Page 44 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867286
Page 45 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867287
Page 46 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867288
Page 47 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867289
Page 48 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867290
Page 49 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867291
Page 50 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867292
Page 51 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867293
Page 52 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: OXYGENATION PARAMETERS
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867294
Page 53 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867295
Page 54 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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.Start Date: //
6.Ongoing?
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867296
Page 55 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867297
Page 56 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867298
Page 57 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867299
Page 58 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BRXPSS]
5.bSample ID [BRXPT6]
5.cSample ID [BPT7PX]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867300
Page 59 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867301
Page 60 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867302
Page 61 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867303
Page 62 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867304
Page 63 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867305
Page 64 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867306
Page 65 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867307
Page 66 of 208
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867308
Page 67 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867309
Page 68 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867310
Page 69 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867311
Page 70 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867312
Page 71 of 208
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867313
Page 72 of 208
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867314
Page 73 of 208
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867315
Page 74 of 208
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867316
Page 75 of 208
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867317
Page 76 of 208
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867318
Page 77 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identifi
erAdverse Even
tStart DateIs the Adverse Event Still Ongo
ingForm Instance
 1.ADVERSE EVEN
T 1  Osteochondriti
s Sep/5/2020 12:0
0 NO
End Date Time:
Sep/6/2020 13:31
 Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867319
Page 78 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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)[Osteochondritis]
4.Start Date Time: Sep/5/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/6/2020 13:31
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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867320
Page 79 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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]
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[2020346129]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867321
Page 80 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867322
Page 81 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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[ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867323
Page 82 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867324
Page 83 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: //
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867325
Page 84 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867326
Page 85 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867327
Page 86 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867328
Page 87 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867329
Page 88 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867330
Page 89 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867331
Page 90 of 208
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867332
Page 91 of 208
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867333
Page 92 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867334
Page 93 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867335
Page 94 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867336
Page 95 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/7/2020
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867337
Page 96 of 208
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867338
Page 97 of 208
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-12-2021 10:40:09 (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.
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867339
Page 98 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-20-2020 09:56:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867340
Page 99 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Oct-30-2020 08:25:05 (UTC-03:00) City of
Buenos Aires
2Oct-30-2020 08:23:09 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867341
Page 100 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-04-2020 10:24:31 (UTC-03:00) City of
Buenos Aires
3Oct-30-2020 08:29:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867342
Page 101 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormNov-04-2020 10:16:02 (UTC-03:00) City of
Buenos Aires
FormOct-30-2020 08:21:44 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867343
Page 102 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
1Nov-04-2020 10:16:02 (UTC-03:00) City of
Buenos Aires
1Oct-30-2020 08:21:44 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867344
Page 103 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
2Nov-04-2020 10:16:02 (UTC-03:00) City of
Buenos Aires
2Oct-30-2020 08:21:44 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867345
Page 104 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
3Nov-04-2020 10:16:02 (UTC-03:00) City of
Buenos Aires
3Oct-30-2020 08:21:44 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867346
Page 105 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
4Nov-04-2020 10:16:02 (UTC-03:00) City of
Buenos Aires
4Oct-30-2020 08:21:44 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867347
Page 106 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-12-2021 10:40:09 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-10-2021 11:53:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Feb-22-2021 16:12:14 (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.
 N/A Feb-17-2021 14:28:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0867348
Page 107 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
 Approved Jan-21-2021 11:16:00 (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.
Santiago
Corradetti N/A Jan-07-2021 03:53:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-06-2020 13:43:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-04-2020 10:16:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-02-2020 09:52:03 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0867349
Page 108 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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.
Mabel Berrueta  N/A Oct-30-2020 21:07:58 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-30-2020 15:47:01 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-30-2020 08:15:28 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-22-2020 01:10:48 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0867350
Page 109 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 09:55:01
(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-20-2020 09:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867351
Page 110 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 09:55:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867352
Page 111 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020 23:44:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed AE CRF added
Sep-16-2020 10:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered AE CRF was completed.
Thank you.
Sep-08-2020 06:43:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020346129
Osteochondritis(onset
date:05Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-19-2020 16:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12312390Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 16:52:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1995Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 09:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867353
Page 112 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 09:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 09:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867354
Page 113 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 09:55:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867355
Page 114 of 208
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umber
:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65 a
nd 85 years, inclusive, or 1
8 and 85 years, inclusive, a
t randomization (dependen
t upon study 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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at rando
mization (dependent upon study sta
ge)Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867356
Page 115 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.a Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vacc
ination plan, laboratory te
sts, lifestyle consideration
s, and other study procedu
res
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867357
Page 116 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and ab
le to comply with all scheduled visi
ts, vaccination plan, laboratory tests
, lifestyle considerations, and other
study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867358
Page 117 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Healthy participants who
are determined by medical
history, physical examinati
on, and clinical judgment
of the investigator to be el
igible for inclusion in the
study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867359
Page 118 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgment
of the investigator to be eligible for
inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867360
Page 119 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Capable of giving persona
l signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the
ICD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867361
Page 120 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed i
nformed consent, which includes c
ompliance with the requirements an
d restrictions listed in the ICD and i
n this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867362
Page 121 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active s
uicidal ideation/behavior/l
ab abnormality that may in
crease the risk of study par
ticipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condit
ion incl. recent (within past year) or
active suicidal ideation/behavior/la
b abnormality that may increase the
risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867363
Page 122 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatitis
B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX02A00Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867364
Page 123 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human immu
nodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus
(HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyla
xis) to any component of t
he study intervention(s)Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867365
Page 124 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction a
ssociated with a vaccine and/or sev
ere allergic reaction (eg, anaphylaxi
s) to any component of the study in
tervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867366
Page 125 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867367
Page 126 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised ind
ividuals with known or su
spected immunodeficienc
y, as determined by histor
y and/or laboratory/physi
cal examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX08A00Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867368
Page 127 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examina
tionInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867369
Page 128 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with prol
onged bleeding that woul
d, in the opinion of the in
vestigator, contraindicate i
ntramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867370
Page 129 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding tha
t would, in the opinion of the invest
igator, contraindicate intramuscular
injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867371
Page 130 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastf
eedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any corona
virus vaccine
Criterion met
?:NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867372
Page 131 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion ID:
(For Pfizer us
e only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coro
navirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:13Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867373
Page 132 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive ther
apy, such as cytotoxic a
gents or systemic cortic
osteroids
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic ag
ents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867374
Page 133 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administra
tion or planned receipt thr
oughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX14A01Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867375
Page 134 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products o
r immunoglobulin, from 60 days be
fore study intervention administrati
on or planned receipt throughout th
e studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867376
Page 135 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descr
iption:Participation in other stu
dies involving study inte
rvention within 28 days
prior to study entry and/
or during study participa
tion
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867377
Page 136 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies invol
ving study intervention within 28 d
ays prior to study entry and/or duri
ng study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:17
Criterion
Descripti
on:Previous participation i
n other studies involvin
g study intervention co
ntaining lipid nanoparti
clesInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867378
Page 137 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other stud
ies involving study intervention co
ntaining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu22Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867379
Page 138 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
mber:
Criter
ion De
scripti
on:Investigator site staff or Pf
izer employees directly in
volved in the conduct of t
he study, site staff otherwi
se supervised by the invest
igator, and their respective
family members
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867380
Page 139 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer emp
loyees directly involved in the con
duct of the study, site staff otherwis
e supervised by the investigator, an
d their respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-20-2020 09:55:49
(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-20-2020 09:55:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867381
Page 140 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 09:56:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 09:56:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 09:56:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867382
Page 141 of 208
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
110.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
170.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.1Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867383
Page 142 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.a
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 09:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867384
Page 143 of 208
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867385
Page 144 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Sponsor-Define
d Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020 09:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867386
Page 145 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 09:57:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 09:57:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
57348Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867387
Page 146 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 09:57:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 09:57:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 16:51:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 12:49:23
(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-20-2020 09:57:59
(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-20-2020 09:57:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867388
Page 147 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-22-2020 16:51:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHY501Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 16:51:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHY501Initial Entry
5.b
Date Location User Value Reason
Aug-22-2020 16:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHY502Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 16:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHY502Initial Entry
5.c
Date Location User Value Reason
Aug-22-2020 16:51:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHY503Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 16:51:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHY503Initial Entry
5.d
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867389
Page 148 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-23-2020 11:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ527ZInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-23-2020 11:47:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ527ZInitial Entry
5.e
Date Location User Value Reason
Aug-23-2020 11:47:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ5281Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-23-2020 11:47:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ5281Initial Entry
5.f
Date Location User Value Reason
Aug-23-2020 11:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ5280Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-23-2020 11:47:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ5280Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867390
Page 149 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 09:58:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 09:58:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 12:30:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 12:49:23
(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-20-2020 09:58:06
(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-20-2020 09:58:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
5.a
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867391
Page 150 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-22-2020 12:30:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHY4VDInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 12:30:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHY4VDInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867392
Page 151 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/19/2020 17:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867393
Page 152 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7. Route:
Date Location User Value Reason
Aug-20-2020 09:58:26
(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-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-20-2020 09:58:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867394
Page 153 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020 09:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867395
Page 154 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 18:00:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867396
Page 155 of 208
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 18:01:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020 18:01:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 18:01:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-09-2020 18:01:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020 18:01:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867397
Page 156 of 208
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 18:01:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867398
Page 157 of 208
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867399
Page 158 of 208
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020 18:01:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867400
Page 159 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 18:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 18:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 12:01:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 02:11:41
(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-09-2020 18:01:41
(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-09-2020 18:01:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867401
Page 160 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-10-2020 12:01:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BP1YSCInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 12:01:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP1YSCInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867402
Page 161 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/9/2020 10:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867403
Page 162 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020 18:02:14
(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-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-09-2020 18:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867404
Page 163 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 02:54:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-15-2020 13:12:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The information was
uploaded Thank you
Oct-14-2020 03:15:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Patient
completed the
treatment phase and
reached at Visit 3.
Kindly consider to
update EOT form
with matching V3
date or else clarify.
Thank you.
Oct-07-2020 19:45:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867405
Page 164 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 17:14:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 17:14:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 17:14:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 17:14:35
(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-07-2020 17:14:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 17:14:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLDYYPInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867406
Page 165 of 208
***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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 17:14:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLDYYPInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 18:40:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW77WInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 18:40:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPW77WInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLDYXTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 19:45:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLDYXTInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867407
Page 166 of 208
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 11:53:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/9/2021Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0867408
Page 167 of 208
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 11:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 11:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 12:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 11:54:05
(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.
Mar-10-2021 11:54:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/9/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021 12:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR1PKGInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867409
Page 168 of 208
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 12:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR1PKGInitial Entry
5.b
Date Location User Value Reason
Mar-10-2021 12:30:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRYX9ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-10-2021 12:30:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRYX9ZInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021 12:30:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRYX99Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-10-2021 12:30:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRYX99Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867410
Page 169 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 03:36:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Closed Per response, query
closed and to be
reported under PD
tracker.
Feb-19-2021 09:39:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Answered The subject reported
that he had covid
symptoms, when he
had more than 4
days without
presenting
symptoms, for that
reason no home visit
was made and no
samples were taken.
Thank you.
Feb-19-2021 06:17:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Opened PDQ: Date of Visit
is completed but
Date of Collection
in both Nasal Swab
Self and Nasal Swab
are missing. Please
review and update
as appropriate.
Feb-18-2021 14:01:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Feb-18-2021 14:01:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sep/16/2020Transcription Error
Nov-06-2020 02:59:02
(UTC-03:00) City ofACV0PFEINFP6000  Query 3: Closed As per site
confirmation -
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867411
Page 170 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires updated PD tracker
Nov-05-2020 08:44:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Analia Castellano Query 3: Answered Not done.
Nov-05-2020 06:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened PDQ : Details of
Sample ID and
collection date for
either Nasal Swab
Self or Nasal Swab
expected to be
completed. Please
check and update
else clarify.
Nov-04-2020 10:16:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Nov-02-2020 16:20:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 08:34:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Changed data per
query
Nov-02-2020 07:06:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-30-2020 08:15:27
(UTC-03:00) City ofACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867412
Page 171 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires of Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-30-2020 08:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Oct-30-2020 08:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-18-2021 18:46:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:02:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Query 1: Answered Changed data per
query
Feb-17-2021 13:10:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per medical chart,
DOV was 16 SEP
2020. Please,
review and modify
if necessary
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-30-2020 08:15:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867413
Page 172 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-18-2021 18:47:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-18-2021 14:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-18-2021 14:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sep/16/2020Transcription Error
Feb-18-2021 14:01:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of assessment
is not same as Date
Visit. Please check
and correct.
Feb-17-2021 13:12:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per medical chart,
Date of assessment
was 16 SEP 2020.
Please, review and
modify if necessary
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-18-2021 18:48:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:03:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867414
Page 173 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-18-2021 14:03:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sep/16/2020Transcription Error
Feb-17-2021 13:13:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per medical chart,
Date of First
Symptom Started
was 16 SEP 2020.
Please, review and
modify if necessary
Oct-30-2020 21:08:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Sep/10/2020Initial Entry
Oct-30-2020 08:25:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-30-2020 08:23:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-18-2021 18:48:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-18-2021 14:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
NO
Date of Last Symptom Resolv
ed:
Sep/18/2020Transcription Error
Feb-17-2021 13:14:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per medical chart,
Date of Last
Symptom Resolved
was 18 SEP 2020.
Please, review and
modify if necessary
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867415
Page 174 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-31-2020 18:07:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolv
ed:
Sep/16/2020New Information
Oct-30-2020 21:08:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
NOInitial Entry
4.a
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867416
Page 175 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.b Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BRE
ATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867417
Page 176 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867418
Page 177 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.f
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:YESInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867419
Page 178 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.g Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867420
Page 179 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.i Symptoms:
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-30-2020 08:16:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867421
Page 180 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867422
Page 181 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-18-2021 18:45:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 17:56:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-18-2021 17:56:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Data Entry:
Sep/16/2020Transcription Error
Feb-17-2021 13:15:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per medical chart,
Actual Date of
Collection: 16 SEP
2020. Please, review
and modify if
necessary
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User ValueReason
Nov-04-2020
11:55:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-04-2020
10:24:52ACV0PFEINFP6000  auto query
(autoquery)Query
1: AnInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867423
Page 182 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of
Buenos Airesswere
d
Nov-04-2020
10:24:52
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
NAS
OPH
ARY
NXInitial Entry
Nov-04-2020
10:24:31
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:Initial Entry
Nov-04-2020
06:49:33
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5246748;Specimen
Collection Location is
not expected to be
Unknown or Not
Applicable. Please
review and update
appropriately or clarify
Oct-30-2020
08:29:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867424
Page 183 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
6. Trade Name:
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-30-2020 08:17:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NALT UnknownInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867425
Page 184 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 08:21:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 08:21:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 08:21:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-30-2020 08:21:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
At visit 3, subject declares SWAB c
ollected outside the study.Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867426
Page 185 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 10:16:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
Nov-04-2020 10:16:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-30-2020 08:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 10:16:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
Nov-04-2020 10:16:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-30-2020 08:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020
12:15:36
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Close
dResponse satisfies
query
Nov-04-2020
10:16:24
(UTC-03:00)
City ofACV0PFEINFP6000  auto query
(autoquery)Query 1
: Answ
eredInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867427
Page 186 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Nov-04-2020
10:16:24
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
NOInitial Entry
Nov-04-2020
10:16:02
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:Initial Entry
Nov-04-2020
04:43:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2
: Delete
dRequery already
present
Nov-04-2020
01:38:08
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Reissu
ed:Ope
nedThis form should not
be marked Not Done /
Not Applicable. Please
complete this form. If
the sample was not
obtained then Sample
Collected = No. A
Sample Comments box
should be entered with
reason sample not
collected.
Nov-03-2020
17:06:17
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Answ
eredThe subject reported
that he had covid
symptoms, when he
had more than 4 days
without presenting
symptoms, for that
reason no home visit
was made and no
samples were taken.
Thank you.
Nov-03-2020
12:58:39
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2
: Candi
dateDMW5244452;Sample
Collected is not
expected to be Not
Done. Please review
and update
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867428
Page 187 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
appropriately or clarify
Nov-03-2020
12:33:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Opene
dDM: Per CCG either
Nasal SWAB Self or
Nasal SWAB is
expected to be
collected. Kindly
verify & update the
data as appropriate;
else clarify. Thanks
Oct-30-2020
08:21:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Not Do
neInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-04-2020 10:16:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample not collectedInitial Entry
Nov-04-2020 10:16:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-30-2020 08:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867429
Page 188 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGENCY
ROOM
Occurrence of V
isits or Contacts
:YES
Number of Visi
ts or Contacts:
1Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867430
Page 189 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867431
Page 190 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867432
Page 191 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-30-2020 08:22:50
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0867433
Page 192 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0867434
Page 193 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-30-2020 21:07:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-30-2020 21:07:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-07-2021 08:53:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-07-2021 03:53:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-07-2021 03:53:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiData Entry:
2Transcription Error
Jan-06-2021 12:46:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Per medical chart,
Toxicity Grade is 2.
Please, review and
modify if necessary
Oct-30-2020 21:07:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
1Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867435
Page 194 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 13:23:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-30-2020 13:27:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-30-2020 08:29:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered On visit 3, subject
declared swabbing
outside the study.
We have updated the
COVID form with
the information
available. Thank
you.
Oct-27-2020 15:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM Query: Subject
has completed
Convalescent visit,
however
corresponding
COVID illness visit
is not recorded.
Please review and
update the details as
appropriate. Thank
you.
Oct-13-2020 13:26:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0867436
Page 195 of 208
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 13:24:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 13:24:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 17:25:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 13:24:18
(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-13-2020 13:24:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 17:25:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXPSSInitial Entry
090177e196ae2e62\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0867437
Page 196 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/13/2020Form: 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: 12312390 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 17:25:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRXPSSInitial Entry
5.b
Date Location User Value Reason
Oct-13-2020 17:27:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXPT6Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 17:27:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRXPT6Initial Entry
5.c
Date Location User Value Reason
Oct-13-2020 18:13:07
(UTC-03:00) City of
Buenos AiresACV
…[truncated]