125742 S1 M5 CRF c4591001 1231 12312577

Document text

Page 1 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868317
Page 2 of 200
***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: 12312577 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/20/2020
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868318
Page 3 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12312577]
2.Birth Date: /1974
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0868319
Page 4 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868320
Page 5 of 200
***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: 12312577 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
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868321
Page 6 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868322
Page 7 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868323
Page 8 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868324
Page 9 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[lung adenocarcinoma]
Start Date: Jul/1/2019
Ongoing: NO
End Date:
Jan/7/2020
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypothyroidism]
Start Date: Dec/13/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Left Lobectomy]
Start Date: Jan/7/2020
Ongoing: NO
End Date:
Jan/7/2020
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Thyroidectomy]
Start Date: Dec/13/2019
Ongoing: NO
End Date:
Dec/13/2019
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Depressive syndrome]
Start Date: Oct/1/2019
Ongoing: YES
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868325
Page 10 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [91.0]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [32.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868326
Page 11 of 200
***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: 12312577 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/20/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868327
Page 12 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [58799]
3.Randomization Group: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868328
Page 13 of 200
***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: 12312577 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/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHXVPP]
5.bSample ID [BHXVPR]
5.cSample ID [BHXVPS]
5.dSample ID [BJ52X2]
5.eSample ID [BJ52X3]
5 fSample ID [BJ52X4]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868329
Page 14 of 200
***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: 12312577 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/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHXVW9]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868330
Page 15 of 200
***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: 12312577 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/20/2020 14:58
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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868331
Page 16 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868332
Page 17 of 200
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868333
Page 18 of 200
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L 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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868334
Page 19 of 200
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868335
Page 20 of 200
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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/10/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2BLL]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868336
Page 21 of 200
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L 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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868337
Page 22 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868338
Page 23 of 200
***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: 12312577 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[V3 was carried out by telephone because the subject does not want to attend to the
medical center because of her underlying illness]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868339
Page 24 of 200
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868340
Page 25 of 200
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868341
Page 26 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868342
Page 27 of 200
***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: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868343
Page 28 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868344
Page 29 of 200
***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: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868345
Page 30 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868346
Page 31 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/18/2021
2.Date of First Symptom Started: Feb/12/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/21/2021
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
Symptoms - Other
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868347
Page 32 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.aSymptoms - Other Text: [increased body temperature]
5.bSymptoms - Other Text: [nasal congestion]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868348
Page 33 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Feb/18/202
1 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868349
Page 34 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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: Feb/18/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868350
Page 35 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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:[sample collected by team pyhsician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868351
Page 36 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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:
Feb/18/2021
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 [BRM92V]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868352
Page 37 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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: NO
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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868353
Page 38 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868354
Page 39 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868355
Page 40 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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?YES
Respiratory Illness Diagnosis:
[upper airway catarrh]
Date of Diagnosis:
Feb/12/2021
3.Toxicity Grade: 1
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868356
Page 41 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868357
Page 42 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868358
Page 43 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868359
Page 44 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868360
Page 45 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868361
Page 46 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868362
Page 47 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868363
Page 48 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868364
Page 49 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868365
Page 50 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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 % [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868366
Page 51 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868367
Page 52 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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): [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868368
Page 53 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868369
Page 54 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868370
Page 55 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868371
Page 56 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868372
Page 57 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868373
Page 58 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868374
Page 59 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868375
Page 60 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868376
Page 61 of 200
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Aug/28/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868377
Page 62 of 200
***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: 12312577 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: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868378
Page 63 of 200
***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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868379
Page 64 of 200
***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: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868380
Page 65 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868381
Page 66 of 200
***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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868382
Page 67 of 200
***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: 12312577 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:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868383
Page 68 of 200
***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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868384
Page 69 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868385
Page 70 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868386
Page 71 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868387
Page 72 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868388
Page 73 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868389
Page 74 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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 [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868390
Page 75 of 200
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868391
Page 76 of 200
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868392
Page 77 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identifi
erAdverse Even
tStart DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVEN
T 1  Brain metastasi
s Aug/28/2020 UNK:U
NK YES  Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868393
Page 78 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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)[Brain metastasis]
4.Start Date Time: Aug/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[history of primary lung adenocarcinoma]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication given? YES
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868394
Page 79 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT 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[2020354651]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868395
Page 80 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868396
Page 81 of 200
***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: 12312577 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[ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868397
Page 82 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868398
Page 83 of 200
***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: 12312577 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: //
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868399
Page 84 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868400
Page 85 of 200
***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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868401
Page 86 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868402
Page 87 of 200
***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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868403
Page 88 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868404
Page 89 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868405
Page 90 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868406
Page 91 of 200
***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: 12312577 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?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868407
Page 92 of 200
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868408
Page 93 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868409
Page 94 of 200
***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: 12312577 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: [ ]
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868410
Page 95 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/28/2020
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868411
Page 96 of 200
***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: 12312577 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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868412
Page 97 of 200
***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: 12312577 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-16-2021 21:05:22 (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.
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0868413
Page 98 of 200
***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: 12312577 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-16-2021 21:05:22 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina Davalli  N/A Feb-19-2021 17:41:32 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Jan-22-2021 18:12:30 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, 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 Dec-03-2020 12:28:42 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-06-2020 13:54:02 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0868414
Page 99 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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.
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0868415
Page 100 of 200
***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: 12312577 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 17:02:27
(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 17:02:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868416
Page 101 of 200
***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: 12312577 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 17:02:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868417
Page 102 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-20-2020 12:11:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed event entered in Inform
Sep-19-2020 15:00:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The SAE was loaded on
09/16/2020. Thank you.
Sep-15-2020 07:19:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020354651
Unespecific brain lesion
(onset date:28-
Aug-2020)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-20-2020 13:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12312577Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 13:24:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1974Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 17:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 17:03:07
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OFInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868418
Page 103 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 17:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868419
Page 104 of 200
***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: 12312577 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 17:03:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868420
Page 105 of 200
***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: 12312577 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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion Nu
mber:1
Criter
ion De
scripti
on:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and
85 years, inclusive, or 18 a
nd 85 years, inclusive, at ra
ndomization (dependent up
on study stage)
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomiza
tion (dependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868421
Page 106 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willin
g and able to comply with
all scheduled visits, vaccin
ation plan, laboratory tests,
lifestyle considerations, an
d other study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN02A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868422
Page 107 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and abl
e to comply with all scheduled visits
, vaccination plan, laboratory tests, l
ifestyle considerations, and other stu
dy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who a
re determined by medical h
istory, physical examinatio
n, and clinical judgment of
the investigator to be eligib
le for inclusion in the stud
yInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868423
Page 108 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0868424
Page 109 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determ
ined by medical history, physical ex
amination, and clinical judgment of
the investigator to be eligible for inc
lusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Oct-02-2020 19:10:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-02-2020 17:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina Davalli Query 2: Answered Regarding said
antecedent, the
volunteer underwent a
left lobectomy on
01/07/2020 which was
considered curative,
without requiring
other therapies or
interventions. It was
stable at the time of
inclusion in the study.
Thank you.
Oct-01-2020 16:30:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINQUERY: given
the subject's history of
lung adenocarcinoma,
please clarify if the
disease was
considered stable and
the subject was
eligible per inclusion
criterion #3 at visit 1.
Sep-30-2020 15:48:14
(UTC-03:00) City ofACV0PFEINFP6000  Query 1: Closed not necessary
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868425
Page 110 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Sep-30-2020 14:20:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: given
the subject's history of
lung adenocarcinoma,
please clarify if the
disease was
considered stable and
the subject was
eligible per inclusion
criterion #3.
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the I
CD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868426
Page 111 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed i
nformed consent, which includes co
mpliance with the requirements and
restrictions listed in the ICD and in t
his protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020 18:06:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1
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
ticipationTranscription Error
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868427
Page 112 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
Oct-05-2020 10:48:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1
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
?:YES
Criteri
on ID:
(For P
fizer u
se only
):EX01A00New Information
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1
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
?:NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868428
Page 113 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric conditi
on incl. recent (within past year) or
active suicidal ideation/behavior/lab
abnormality that may increase the ri
sk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Oct-27-2020
14:24:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Cl
osedResponse satisfies
query
Oct-26-2020
14:56:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Julieta Gelardi Query 4: An
sweredAt the discretion of
the principal
investigator, the
pathology was stable
at the time of
inclusion in the study
Oct-23-2020
12:10:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Op
enedClinQuery: a deviation
has been raised that
Participant met
exclusion criterion
#01, this data is also
reflected in the med
Hx CRF. Please
review and update this
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868429
Page 114 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
CRF else clarify.
Oct-08-2020
22:46:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: Cl
osedAuto closed by
Validation Check:
VC_IE001_02
Oct-08-2020
21:04:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Cl
osedResponse satisfies
query
Oct-08-2020
18:06:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: An
sweredTranscription Error
Oct-08-2020
18:06:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: An
sweredTranscription Error
Oct-08-2020
18:06:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-06-2020
17:11:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Op
enedCLINQUERY: please
clarify why excl
criteria 1 is now
updated to YES
(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)
Oct-05-2020
16:41:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: Op
enedDMW4891423;[PDQ]
An Exclusion
'Criterion Met' is
recorded as YES, and
the 'Status' on the
Disposition -
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868430
Page 115 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Screening form is not
SCREEN FAILURE.
Please review and
correct or confirm.
Oct-05-2020
10:53:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies
query
Oct-05-2020
10:48:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredNew Information
Oct-05-2020
10:48:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESNew Information
Oct-03-2020
20:58:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Op
enedDue to a clarification
dated 03-Oct-2020,
subject had a
diagnosis of
depressive syndrome
within the last year.
Please verify the
clarification note and
amend this entry to
yes. Thank you.
Aug-20-2020
17:03:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868431
Page 116 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency v
irus (HIV), hepatitis C vi
rus (HCV), or hepatitis B
virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868432
Page 117 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse r
eaction associated with a v
accine and/or severe allerg
ic reaction (eg, anaphylaxi
s) to any component of the
study intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868433
Page 118 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction a
ssociated with a vaccine and/or seve
re allergic reaction (eg, anaphylaxis)
to any component of the study inter
vention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicati
ons intended to prev
ent COVID-19
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868434
Page 119 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or sus
pected immunodeficiency,
as determined by history a
nd/or laboratory/physical
examination
Criteri
on met
?:NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868435
Page 120 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For Pf
izer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals w
ith known or suspected immunodefi
ciency, as determined by history and
/or laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868436
Page 121 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Bleeding diathesis or cond
ition associated with prolo
nged bleeding that would,
in the opinion of the invest
igator, contraindicate intra
muscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition asso
ciated with prolonged bleeding that
would, in the opinion of the investig
ator, contraindicate intramuscular in
jectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868437
Page 122 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868438
Page 123 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinatio
n with any coronav
irus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868439
Page 124 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic agen
ts or systemic corticoste
roids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868440
Page 125 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic age
nts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-20-2020 17:03:39
(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
?:NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868441
Page 126 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For Pf
izer use
only):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befo
re study intervention administration
or planned receipt throughout the st
udyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
2.k
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:16Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868442
Page 127 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Participation in other stud
ies involving study interv
ention within 28 days pri
or to study entry and/or d
uring study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01
2.k Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868443
Page 128 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation i
n other studies involvin
g study intervention con
taining lipid nanoparticl
es
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX16A01Initial Entry
2.l Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studi
es involving study intervention cont
aining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868444
Page 129 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the s
tudy, site staff otherwise su
pervised by the investigator
, and their respective famil
y members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868445
Page 130 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-20-2020 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise s
upervised by the investigator, and th
eir respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-20-2020 17:03:39
(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 17:03:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868446
Page 131 of 200
***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: 12312577 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 17:03:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 17:03:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 17:03:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868447
Page 132 of 200
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 14:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:1
Medical History
Term:lung adenocarci
noma
Start Date: Jul/1/2019
Ongoing: NO
End Date:
Jan/7/2020Transcription Error
Aug-22-2020 17:18:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Line/MH Numbe
r:1
Medical History
Term:lung adenocarci
noma
Start Date: Jul/1/2019
Ongoing: YESChanged Information
Aug-20-2020 17:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:lung adenocarcinoma
and separate left lobec
tomy
Start Date: Jul/1/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020 17:26:52
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020
15:41:21ACV0PFEINFP6000  Query 2: Clos
edResponse satisfies
query
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868448
Page 133 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
Aires
Aug-27-2020
15:00:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Ans
wereddone
Aug-26-2020
15:41:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Reis
sued:OpenedGPD Clinical, a stop
date of 07Jan2020 was
provided for lung
adenocarcinoma in
response to the query.
Please update this
medical history entry
with this stop date.
Aug-25-2020
20:37:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Ans
weredLung adenocarcinoma
from 07/01/2019 to
01/07/2020. Not
currently continuing.
Thank you
Aug-24-2020
17:59:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Ope
nedGPD Clinical, please
clarify if lung
adenocarcinoma is
ongoing, and if so
please clarify if the
subject is receiving
treatment. Please clarify
if the subject may be
immunocompromised.
Aug-23-2020
13:29:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Clos
edDiscrepancy has been
closed.
Aug-22-2020
17:18:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredChanged Information
Aug-22-2020
17:18:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
lung adenocar
cinomaChanged Information
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868449
Page 134 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-22-2020
16:28:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Ope
nedMultiple concepts in
the term LUNG
ADENOCARCINOMA
AND SEPARATE
LEFT LOBECTOMY.
Split the term into
LUNG
ADENOCARCINOMA
and SEPARATE LEFT
LUNG LOBECTOMY
and submit separately.
Thank you.
Aug-20-2020
17:26:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
lung adenocar
cinoma and se
parate left lob
ectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-02-2020 13:38:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Samuel Dychter Query 1: Closed Response satisfies
query
Oct-01-2020 13:20:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-29-2020 17:23:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Samuel Dychter Query 1: Opened GPD Clin: Please
confirm the actual
start date, since this
is the same date as
the lobectomy. It
would be unusual for
the date of diagnosis
to be the same date
as the surgery.
Aug-20-2020 17:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jul/1/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-02-2020 13:39:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Samuel Dychter Query 1: Closed Response satisfies
query
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868450
Page 135 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-01-2020 13:20:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-29-2020 17:19:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Samuel Dychter Query 1: Opened GPD Clin: Please
clarify why the stop
date for the lung
cancer was in 2020,
when the subject had
a lobectomy on 1 Jul
2019. Was additional
treatment for the
cancer conducted?
Please clarify.
Aug-27-2020 14:59:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/7/2020Transcription Error
Aug-20-2020 17:26:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-22-2020 17:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Line/MH Number: 2
Medical History Te
rm:Hypothyroidi
sm
Start Date: Dec/13/2019
Ongoing: YESChanged Information
Aug-20-2020 17:27:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term:hypothyroidism thyroi
dectomy thyroid nodul
e
Start Date: Dec/13/2019
Ongoing: YESInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868451
Page 136 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Line/MH Number:
Date Location User Value Reason
Aug-20-2020 17:27:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-23-2020
13:30:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Close
dDiscrepancy has been
closed.
Aug-22-2020
17:23:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredChanged Information
Aug-22-2020
17:23:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Hypothyroidis
mChanged Information
Aug-22-2020
16:28:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Open
edMultiple concepts in
the term
HYPOTHYROIDISM
THYROIDECTOMY
THYROID NODULE.
Split the term into
Split the term into
HYPOTHYROIDISM
and
THYROIDECTOMY
and THYROID
NODULE and report
as 3 separate entries.
Thank you.
Aug-20-2020
17:27:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
hypothyroidis
m thyroidecto
my thyroid nod
uleInitial Entry
1.b Start Date:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868452
Page 137 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-20-2020 17:27:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/13/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-20-2020 17:27:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-01-2020 13:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Number: 3
Medical History Ter
m:Left Lobectom
y
Start Date: Jan/7/2020
Ongoing: NO
End Date:
Jan/7/2020Transcription Error
Oct-01-2020 13:18:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Number: 3
Medical History Ter
m:Left Lobectom
y
Start Date: Jul/1/2019
Ongoing: NO
End Date:
Jan/7/2020Transcription Error
Aug-22-2020 17:23:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Left Lobectom
y
Start Date: Jul/1/2019
Ongoing: NO
End Date:
Jul/1/2019Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868453
Page 138 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Line/MH Number:
Date Location User Value Reason
Aug-22-2020 17:23:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 17:23:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Left LobectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-02-2020 15:54:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-01-2020 13:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-01-2020 13:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/7/2020Transcription Error
Oct-01-2020 10:13:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINICAL SAE
report information
states Lt lung
Lobectomy procedure
date was 07 Jan 2020;
however, medical
history has a 2019
date. Please review
and update as
appropriate
Aug-22-2020 17:23:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Jul/1/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-01-2020 13:18:13
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NOTranscription Error
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868454
Page 139 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires End Date:
Jan/7/2020
Aug-22-2020 17:23:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
NO
End Date:
Jul/1/2019Initial Entry
1.d
Date Location User Value Reason
Aug-22-2020 17:25:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Thyroidectom
y
Start Date: Dec/13/2019
Ongoing: NO
End Date:
Dec/13/201
9Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868455
Page 140 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Line/MH Number:
Date Location User Value Reason
Aug-22-2020 17:25:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 17:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
ThyroidectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-22-2020 17:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
Dec/13/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-05-2020 10:53:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0868456
Page 141 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.d Ongoing:
Date Location User Value Reason
Oct-05-2020 10:46:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The entry was added.
Thank you.
Oct-03-2020 20:49:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Accoring to a
clarification note
dated 03-Oct-2020,
subject has an
ongoing medical
history of depressive
syndrome since
01-OCT-2019. Please
verify and add another
medical history entry.
Thank you!
Aug-22-2020 17:25:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
NO
End Date:
Dec/13/2019Initial Entry
1.e
Date Location User Value Reason
Oct-05-2020 10:44:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Depressive syndr
ome
Start Date: Oct/1/2019
Ongoing: YESInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0868457
Page 142 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.e Line/MH Number:
Date Location User Value Reason
Oct-05-2020 10:44:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-05-2020 10:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Depressive syndromeInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-05-2020 10:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-05-2020 10:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0868458
Page 143 of 200
***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: 12312577 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 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
91.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.2Initial Entry
7.a
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868459
Page 144 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 17:28:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868460
Page 145 of 200
***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: 12312577 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 17:28:31
(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 17:28:31
(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 17:28:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 17:28:31
(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 17:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020 17:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868461
Page 146 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 17:28:31
(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 17:28:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020 17:28:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868462
Page 147 of 200
***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: 12312577 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 17:28:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 17:28:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
58799Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868463
Page 148 of 200
***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: 12312577 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 17:28:44
(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 17:28:44
(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 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 09:56:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Balaji Prabu R Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-20-2020 17:28:44
(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 17:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868464
Page 149 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-22-2020 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHXVPPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 17:25:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHXVPPInitial Entry
5.b
Date Location User Value Reason
Aug-22-2020 17:25:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHXVPRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 17:25:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHXVPRInitial Entry
5.c
Date Location User Value Reason
Aug-22-2020 17:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHXVPSInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 17:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHXVPSInitial Entry
5.d
Date Location User Value Reason
Aug-23-2020 12:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ52X2Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(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-2021-5683-0868465
Page 150 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d Sample ID
Date Location User Value Reason
Aug-23-2020 12:23:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ52X2Initial Entry
5.e
Date Location User Value Reason
Aug-23-2020 12:23:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ52X3Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-23-2020 12:23:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ52X3Initial Entry
5.f
Date Location User Value Reason
Aug-23-2020 12:23:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ52X4Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-23-2020 12:23:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ52X4Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868466
Page 151 of 200
***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: 12312577 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 17:28:50
(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 17:28:50
(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 15:24:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-21-2020 09:56:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Balaji Prabu R Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-20-2020 17:28:50
(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 17:28:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868467
Page 152 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-22-2020 15:24:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHXVW9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 15:24:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHXVW9Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0868468
Page 153 of 200
***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: 12312577 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 17:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 17:29:04
(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 17:29:04
(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 17:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/20/2020 14:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 17:29:04
(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 17:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868469
Page 154 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-20-2020 17:29:04
(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 17:29:04
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-20-2020 17:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868470
Page 155 of 200
***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: 12312577 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 17:29:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868471
Page 156 of 200
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-03-2020 12:28:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/10/2020Transcription Error
Sep-11-2020 16:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868472
Page 157 of 200
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 11:03:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 11:03:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 11:03:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 11:03:02
(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-11-2020 11:03:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 11:03:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2BLLInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0868473
Page 158 of 200
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-11-2020 11:03:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2BLLInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0868474
Page 159 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User ValueReason
Dec-22-2020
03:28:15
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedClosed per SITE response,
added to PD tracker for
Clinical review
Dec-21-2020
12:11:59
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Santiago Corradetti Query
1: Ans
weredDOV at V3 is indeed out of
window for 61 days from V2.
Subject was diagnosed with
brain metastasis of a lung
cancer and it was difficult to
schedule V3 due to all the
appointments she had with her
private health service. Finally
it was done by telephone.
Dec-21-2020
05:52:13
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 61 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Dec-18-2020
13:35:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Dec/1
5/202
0Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868475
Page 160 of 200
***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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 13:39:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 13:39:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 13:39:35
(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
Dec-18-2020 13:39:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
V3 was carried out by telephone becau
se the subject does not want to attend t
o the medical center because of her un
derlying illnessInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868476
Page 161 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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-29-2021 13:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered The convalescence
visit has not yet been
completed because the
subject is undergoing
an adverse event that
makes it impossible to
go to the hospital. It
will be scheduled as
soon as possible.
Mar-29-2021 08:08:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened PDQ: Convalescent
visit is missing and
35+ days (39) have
passed since COVID
Illness Visit. If visit
occurred record data
as a matching
CONVA visit; if visit
did not occur attempt
to schedule visit even
if OOW and obtain
the CONVA sample
else clarify.
Feb-19-2021 17:46:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-19-2021 17:41:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Feb-19-2021 17:41:30
(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
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0868477
Page 162 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nasal Swab are
missing. Please
review and update as
appropriate.
Feb-19-2021 17:41:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/18/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-19-2021 17:41:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868478
Page 163 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/18/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/12/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-12-2021 16:57:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved:
Feb/21/2021New Information
Feb-19-2021 17:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868479
Page 164 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom
s:NEW OR INCREASED
SHORTNESS OF BREA
TH
Symptom
Present:NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868480
Page 165 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.c Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW OR INCREASED SHORTNES
S OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom
Present:NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868481
Page 166 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.e Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW OR INCREASED MUSCLE P
AINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: NEW OR INCREASED
SORE THROATInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868482
Page 167 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptom
Present:YES
4.g Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW OR INCREASED SORE THR
OATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868483
Page 168 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.i Symptoms:
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-19-2021 17:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-24-2021 17:56:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - O
ther:increased body tem
peratureTranscription Error
Feb-23-2021 14:15:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other
:Low grade feve
rTranscription Error
Feb-22-2021 13:20:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
- Other:BODY TEMPERATU
RE INCREASEDTranscription Error
Feb-19-2021 17:42:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms - Other
:low grade feve
rInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Mar-02-2021
16:47:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Katherine Puig Query 1: Close
dEntry may
remain in
Symptoms Other
since temperature
value does not
meet Fever
criteria
Feb-26-2021
11:24:40ACV0PFEINFP6000  Query 1: Reiss
ued:Candidateunsure what
action to take, is
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0868484
Page 169 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
Airesthis permitted to
stay as is?
Feb-25-2021
14:55:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Adolfo Gonzalez Query 1: Answ
eredper protocol
section 8.2.2.4 to
consider fever as
a symptom it
must be greater
than or equal to
38º Celsius
therefore it will
remain like
increased body
temperature as
criteria is not
met, thank you
Feb-25-2021
12:48:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Reiss
ued:OpenedThank you for
your response.
However, that
guidance is not
correct. Please
update "Fever" to
"Yes" and
remove the data
from Symptoms
Other field, else
clarify.
Feb-24-2021
17:56:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Feb-24-2021
17:56:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
increased body
temperatureTranscription
Error
Feb-24-2021
16:00:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Reiss
ued:OpenedThank you for
your response.
However, that
guidance is not
correct. Please
update "Fever" to
"Yes" and
remove the data
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868485
Page 170 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
from Symptoms
Other field, else
clarify.
Feb-23-2021
14:15:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Low grade fev
erTranscription
Error
Feb-23-2021
14:15:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answ
eredSymptom low
grade fever is
being loaded in
"other" according
to previous
queries requests
stating that it is
not considered
the same as fever.
therefore it will
remain as "other -
low grade fever".
Feb-23-2021
06:51:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Reiss
ued:OpenedThank you for
confirming.
Please update
"Fever" to "Yes"
and remove the
data from
Symptoms Other
field, else clarify.
Feb-22-2021
13:20:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Feb-22-2021
13:20:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BODY TEMP
ERATURE IN
CREASEDTranscription
Error
Feb-22-2021
05:44:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Open
edSymptoms Other
field recorded
"low grade
fewer", however
"Fever" in
predefined list is
recorded as "No",
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868486
Page 171 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Kindly confirm
"Fever" needs to
be updated as
"Yes" remove the
data from
Symptoms Other
field, else clarify,
thank you. 
Feb-19-2021
17:42:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Martina Davalli Data Entry:
low grade feve
rInitial Entry
5.b
Date Location User Value Reason
Feb-19-2021 17:42:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptoms - Other
:nasal congestio
nInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-19-2021 17:42:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
nasal congestionInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868487
Page 172 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Martina
DavalliForm Created
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868488
Page 173 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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-19-2021 17:43:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/18/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROME
CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ATILA BIOSYSTEMS IAMP COVI
D-19 DETECTION KITInitial Entry
7. Test Result:
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868489
Page 174 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Feb-19-2021 17:43:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868490
Page 175 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021 17:43:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021 17:43:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021 17:43:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData 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
Feb-19-2021 17:43:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
sample collected by team pyhsicianInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868491
Page 176 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-19-2021 17:46:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-19-2021 17:46:16
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021 12:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 08:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-19-2021 17:46:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-19-2021 17:46:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021 12:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRM92VInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0868492
Page 177 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: 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: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Feb-22-2021 12:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRM92VInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0868493
Page 178 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Type of Practitioner
:EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868494
Page 179 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Type of Practitio
ner:PRIMARY CAR
E PHYSICIAN
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Type of Practitioner: URGENT
CAREInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868495
Page 180 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Occurrence of Visits o
r Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Type of Practitio
ner:TELEPHONE C
ONSULTATION
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-19-2021 17:46:43 ACV0PFEINFP6000  Martina Data Entry: Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868496
Page 181 of 200
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresDavalli Type of Practitioner: OTHE
R
Occurrence of Visits or Co
ntacts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-19-2021 17:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868497
Page 182 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Feb/18/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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
Feb-19-2021 17:47:32
(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
Feb-19-2021 17:47:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Respiratory Illness Diagnosis:
upper airway catarrh
Date of Diagnosis:
Feb/12/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-19-2021 17:47:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0868498
Page 183 of 200
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 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
Sep-11-2020 16:34:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020 16:34:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-10-2020 10:20:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Erica Weaver Query 6: Closed Response satisfies
query
Oct-08-2020 20:51:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-08-2020 18:04:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 6: Answered Volunteer with chronic
oncological disease
which presents a
recurrence evidenced
in an imaging study
carried out on
8/28/2020
Oct-08-2020 18:03:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Oct-08-2020 17:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 6: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check and
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868499
Page 184 of 200
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
correct the data.
Oct-08-2020 17:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Oct-08-2020 17:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-08-2020 17:57:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ADVERSE EVENTTranscription Error
Oct-05-2020 13:50:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY: for the
AE of Brain
metastasis, given that
the Action to Study
Treatment is DRUG
WITHDRAWN,
please confirm that the
status should be
updated to ADVERSE
EVENT, specifying
Brain metastasis.
Oct-03-2020 17:53:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Oct-03-2020 17:42:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to "Status"
is NO LONGER
MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Oct-03-2020 17:42:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Oct-03-2020 17:42:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO LONGER MEETS ELIGIBIL
ITY CRITERIATranscription Error
Oct-03-2020 17:35:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-03-2020 17:35:15
(UTC-03:00) City ofACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Status is reported as
Adverse Event, but
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868500
Page 185 of 200
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check and
correct the data.
Oct-03-2020 17:35:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Oct-03-2020 17:35:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-03-2020 17:35:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ADVERSE EVENTTranscription Error
Sep-30-2020 14:44:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: for the
AE of Brain metastasis
(primary lung
adenocarcinoma),
given that the Action
to Study Treatment is
DRUG
WITHDRAWN,
please confirm that the
status should be
updated to ADVERSE
EVENT.
Sep-11-2020 16:34:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-08-2020 18:03:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Oct-08-2020 18:03:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Volunteer with chronic oncological
disease (EA 08/20/2020)Transcription Error
Oct-03-2020 17:53:01 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0868501
Page 186 of 200
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresHealthy participants who, based on
their medical history, are eligible fo
r inclusion in the study.
Oct-03-2020 17:35:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Sep-11-2020 16:34:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Volunteer with chronic oncological
diseaseInitial Entry
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868502
Page 187 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Sep-16-2020 09:24:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0868503
Page 188 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Sep-16-2020 09:24:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-16-2020 09:24:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-08-2020
11:08:02
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 5:
ClosedResponse satisfies query
Oct-08-2020
11:04:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 4:
ClosedResponse satisfies query
Oct-08-2020
11:04:36
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 5:
Reissued
:OpenedCLINICAL Please
submit a SAE safety
followup which states
the medical condition
treated by Con Med
Quetiapine (currently
'Indication' is blank and
SAE med Hx has no
relevant condition)
Oct-03-2020
17:58:59
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query (autoquery) Query 5:
Answere
dTranscription Error
Oct-03-2020
17:58:59ACV0PFEINFP6000  auto query (autoquery) Query 4:
AnswereTranscription Error
090177e196ae2f1b\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0868504
Page 189 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312577 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of
Buenos Airesd
Oct-03-2020
17:58:59
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
Brain m
etastasisTranscription Error
Oct-01-2020
10:18:27
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 5:
OpenedCLINICAL Please
submit a SAE safety
followup which states
the medical condition
treated by Con Med
Quetiapine (currently
'Indication' is blank and
SAE med Hx has no
relevant condition)
Sep-29-2020
09:06:02
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
Closedclinical query issued on
AE term
Sep-28-2020
15:58:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 4:
OpenedCLINQUERY - For
single term reporting
clarity, consider single
concept of 'Brain
Metastasis' for AE term
with Caus
…[truncated]