125742 S1 M5 CRF c4591001 1231 12311058

Document text

Page 1 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857588
Page 2 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857589
Page 3 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [12311058]
2.Birth Date: 1976
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857590
Page 4 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857591
Page 5 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857592
Page 6 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857593
Page 7 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857594
Page 8 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857595
Page 9 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857596
Page 10 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857597
Page 11 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857598
Page 12 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Chagas disease, AKA American trypanosomiasis]
Start Date: Nov/2/1999
Ongoing: YES
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857599
Page 13 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [66.8]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [26.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857600
Page 14 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
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:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857601
Page 15 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [46370]
3.Randomization Group: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857602
Page 16 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLCK53]
5.bSample ID [BLCK54]
5.cSample ID [BM8HLC]
5.dSample ID [BM8HLD]
5.eSample ID [BM8HLF]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857603
Page 17 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8HKF]
5.bSample ID [BM83T2]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857604
Page 18 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/11/2020 15:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857605
Page 19 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857606
Page 20 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857607
Page 21 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Aug/17/2020
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857608
Page 22 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Aug/17/2020
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857609
Page 23 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857610
Page 24 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857611
Page 25 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
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:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857612
Page 26 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP2735]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857613
Page 27 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/1/2020 12:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857614
Page 28 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857615
Page 29 of 231
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857616
Page 30 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857617
Page 31 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857618
Page 32 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BK6XN6]
5.bSample ID [BPXJ5R]
5.cSample ID [BK6XNL]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857619
Page 33 of 231
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857620
Page 34 of 231
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR22MP]
5.bSample ID [BRYF89]
5.cSample ID [BRYF8J]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857621
Page 35 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857622
Page 36 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857623
Page 37 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857624
Page 38 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857625
Page 39 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857626
Page 40 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857627
Page 41 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857628
Page 42 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857629
Page 43 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857630
Page 44 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857631
Page 45 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857632
Page 46 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857633
Page 47 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857634
Page 48 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857635
Page 49 of 231
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857636
Page 50 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857637
Page 51 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857638
Page 52 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857639
Page 53 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Ide
ntifierAdverse Even
tStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  hearing loss in
the left ear Sep/27/202
0 09:00 NO
End Date Time:
Oct/8/2020 15:00
 Repeating
Pages
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857640
Page 54 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[hearing loss in the left ear]
4.Start Date Time: Sep/27/2020 09:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/8/2020 15:00
6.Toxicity Grade: 1
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857641
Page 55 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Cerum in external auditory canal]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857642
Page 56 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857643
Page 57 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857644
Page 58 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857645
Page 59 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857646
Page 60 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857647
Page 61 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857648
Page 62 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857649
Page 63 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857650
Page 64 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857651
Page 65 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857652
Page 66 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857653
Page 67 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857654
Page 68 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857655
Page 69 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857656
Page 70 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857657
Page 71 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857658
Page 72 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857659
Page 73 of 231
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857660
Page 74 of 231
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857661
Page 75 of 231
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857662
Page 76 of 231
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857663
Page 77 of 231
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857664
Page 78 of 231
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857665
Page 79 of 231
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/12/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857666
Page 80 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857667
Page 81 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857668
Page 82 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/1/2020
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857669
Page 83 of 231
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857670
Page 84 of 231
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857671
Page 85 of 231
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-12-2021 11:34:05 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-22-2021 21:46:59 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-19-2021 12:43:05 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857672
Page 86 of 231
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
N/A
 Approved Nov-15-2020 10:54:23 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Nov-14-2020 17:36:56 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-12-2020 14:45:57 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857673
Page 87 of 231
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Oct-02-2020 10:04:40 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Sep-21-2020 21:10:06 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857674
Page 88 of 231
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857675
Page 89 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020
10:55:13
(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-12-2020
10:55:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857676
Page 90 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020
10:55:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/11/2020Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857677
Page 91 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020
16:52:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311058Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020
16:52:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1976Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020
10:56:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020
10:56:22ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATIInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857678
Page 92 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresNO(A) OR OF SPAN
ISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020
10:56:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857679
Page 93 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020
10:56:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857680
Page 94 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or female
participants bet
ween the ages o
f 18 and 55 yea
rs, inclusive, 65
and 85 years, in
clusive, or 18 a
nd 85 years, inc
lusive, at rando
mization (depe
ndent upon stud
y stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857681
Page 95 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partici
pants between the age
s of 18 and 55 years, i
nclusive, 65 and 85 y
ears, inclusive, or 18
and 85 years, inclusiv
e, at randomization (d
ependent upon study s
tage)Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857682
Page 96 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.a Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(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-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857683
Page 97 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing an
d able to compl
y with all sche
duled visits, va
ccination plan,
laboratory tests
, lifestyle consi
derations, and
other study pro
cedures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857684
Page 98 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.b Inclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857685
Page 99 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are
determined by
medical history
, physical exam
ination, and cli
nical judgment
of the investiga
tor to be eligibl
e for inclusion
in the study
Crit
erio
n m
et?:YESInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857686
Page 100 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857687
Page 101 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.c Inclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined b
y medical history, phy
sical examination, an
d clinical judgment of
the investigator to be
eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857688
Page 102 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:4
Crit
erio
n De
scri
ptio
n:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the r
equirements an
d restrictions li
sted in the ICD
and in this prot
ocol
Crit
erio
n me
t?:YESInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857689
Page 103 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857690
Page 104 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.d Inclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving per
sonal signed informed
consent, which includ
es compliance with th
e requirements and re
strictions listed in the
ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857691
Page 105 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. r
ecent (within p
ast year) or acti
ve suicidal idea
tion/behavior/l
ab abnormality
that may increa
se the risk of st
udy participatio
n
Crit
erio
n m
et?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857692
Page 106 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past ye
ar) or active suicidal i
deation/behavior/lab a
bnormality that may i
ncrease the risk of stu
dy participationInitial Entry
2.a Criterion met?
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857693
Page 107 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Aug-12-2020
10:58:07
(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-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:2
Crite
rion
Descr
iptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857694
Page 108 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857695
Page 109 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.b Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857696
Page 110 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:3
Crit
erio
n De
scri
ptio
n:History of seve
re adverse reac
tion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylaxi
s) to any comp
onent of the stu
dy intervention
(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857697
Page 111 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857698
Page 112 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.c Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adv
erse reaction associate
d with a vaccine and/
or severe allergic reac
tion (eg, anaphylaxis)
to any component of t
he study intervention(
s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857699
Page 113 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descri
ption:Receipt of
medication
s intended t
o prevent C
OVID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857700
Page 114 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.d Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(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-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857701
Page 115 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.e
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with know
n or suspected
immunodeficie
ncy, as determi
ned by history
and/or laborato
ry/physical exa
mination
Crit
erio
n me
t?:NO
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857702
Page 116 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.e Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised
individuals with know
n or suspected immun
odeficiency, as deter
mined by history and/
or laboratory/physical
examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857703
Page 117 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scrip
tion:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inves
tigator, contrai
ndicate intram
uscular injectio
n
Crit
erio
n me
t?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857704
Page 118 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857705
Page 119 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.f Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the
opinion of the investi
gator, contraindicate i
ntramuscular injectio
nInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857706
Page 120 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or br
eastfeedin
g
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX11A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857707
Page 121 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.g Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857708
Page 122 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.h
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX12A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857709
Page 123 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.h Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(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-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857710
Page 124 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.i
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857711
Page 125 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.i Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemic
corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(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-12-2020
10:58:07ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857712
Page 126 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
2.j
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of bloo
d/plasma prod
ucts or immun
oglobulin, fro
m 60 days befo
re study interv
ention adminis
tration or plann
ed receipt thro
ughout the stud
y
Crit
erio
n me
t?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857713
Page 127 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (Fo
r Pfi
zer u
se o
nly):EX14A01
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857714
Page 128 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.j Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857715
Page 129 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857716
Page 130 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
2.k
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studies
involving stud
y intervention
within 28 day
s prior to stud
y entry and/or
during study p
articipation
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857717
Page 131 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.k Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857718
Page 132 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous part
icipation in o
ther studies i
nvolving stud
y interventio
n containing l
ipid nanopart
icles
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857719
Page 133 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.l Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(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-12-2020
10:58:07ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857720
Page 134 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
2.m
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:22
Crit
erio
n D
escr
iptio
n:Investigator sit
e staff or Pfizer
employees dire
ctly involved i
n the conduct o
f the study, site
staff otherwise
supervised by t
he investigator,
and their respe
ctive family m
embers
Crit
erio
n m
et?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857721
Page 135 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857722
Page 136 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.m Exclusion Number:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees d
irectly involved in th
e conduct of the study
, site staff otherwise s
upervised by the inve
stigator, and their res
pective family memb
ersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857723
Page 137 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Aug-12-2020
10:58:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857724
Page 138 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020
10:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020
10:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020
10:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857725
Page 139 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020
11:00:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:1
Medica
l Histo
ry Ter
m:Chagas diseas
e, AKA Amer
ican trypanos
omiasis
Start D
ate:Nov/2/1999
Ongoin
g:YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020
11:00:37
(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
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857726
Page 140 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-30-2020
23:27:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Gary Steven
FriedmanQuery 1: Closed Investigator
confirmed that
participant has
not received
conmed
treatment for
Chagas
Disease
Aug-27-2020
14:33:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
dYou do not
receive
concomitant
medication
Aug-27-2020
06:51:11
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Gary Steven
FriedmanQuery 1: Reissued:
OpenedCHAGAS
DISEASE
remains listed
as ONGOING.
Please confirm
that it HAS or
HAS NOT
BEEN
TREATED.
Aug-20-2020
10:49:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Query 1: Answere
dNo additional
information in
the medical
record, we will
contact the
subject
Aug-17-2020
15:21:31ACV0PFEINFP6000  Gary Steven
FriedmanQuery 1: Opened CHAGAS
DISEASE is
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0857727
Page 141 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00)
City of Buenos
Aireslisted as
ONGOING.
Please confirm
that the
participant did
or did not
receive
treatment for
CHAGAS
DISEASE in
or about 1999
Aug-12-2020
11:00:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Chagas disease, A
KA American tryp
anosomiasisInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020
11:00:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/2/1999Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020
11:00:37
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0857728
Page 142 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857729
Page 143 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
66.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857730
Page 144 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11:02:52
(UTC-03:00) City
of Buenos Aires159.0
5. Unit:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.4Initial Entry
7.a
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.2
Temperatu
re Unit:CInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857731
Page 145 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857732
Page 146 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
11:02:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857733
Page 147 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-12-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857734
Page 148 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11:04:03
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857735
Page 149 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-12-2020
11:04:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857736
Page 150 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020
11:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020
11:05:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
46370Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857737
Page 151 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020
11:05:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020
11:05:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020
08:08:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-13-2020
03:05:15
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Query 1: Opene
d'Sample
Collected?' is
Yes, however
no barcodes
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857738
Page 152 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires are entered.
Please review
and correct as
appropriate.
Aug-12-2020
11:05:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
11:05:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collec
tion:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
08:08:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCK5
3Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857739
Page 153 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-13-2020
08:08:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCK53Initial Entry
5.b
Date Location User Value Reason
Aug-13-2020
08:08:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCK5
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020
08:08:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCK54Initial Entry
5.c
Date Location User Value Reason
Aug-13-2020
08:18:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM8HL
CInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857740
Page 154 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.c Sample ID
Date Location User Value Reason
Aug-13-2020
08:18:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM8HLCInitial Entry
5.d
Date Location User Value Reason
Aug-13-2020
08:19:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM8HL
DInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020
08:19:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM8HLDInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020
08:19:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM8HL
FInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857741
Page 155 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.e Sample ID
Date Location User Value Reason
Aug-13-2020
08:19:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM8HLFInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857742
Page 156 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020
11:06:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020
11:06:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
18:02:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Aug-14-2020
16:49:03
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dThere are
more than 1
barcode
present for
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857743
Page 157 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires sample
collection.
Please review
and correct as
appropriate.
Aug-13-2020
08:13:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-13-2020
03:05:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opene
d'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
11:06:14
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candi
date'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-12-2020
11:06:14
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
YES
Date of Collec
tion:Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857744
Page 158 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires
Aug/11/2020
5.a
Date Location User Value Reason
Aug-13-2020
08:13:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM8HK
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
08:13:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM8HKFInitial Entry
5.b
Date Location User Value Reason
Aug-14-2020
18:02:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample
ID:BM83
T2Transcription
Error
(DELETED)
Aug-14-2020
16:49:03
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
Sample
ID:BM83
T2Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857745
Page 159 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires
5.b Sample ID
Date Location User Value Reason
Aug-14-2020
18:02:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM83T2Transcription
Error
(DELETED)
Aug-14-2020
16:49:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM83T2Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857746
Page 160 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020
11:06:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020
11:06:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020
11:06:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020
11:06:53ACV0PFEINFP6000  Data Entry:
Aug/11/2020 15:59Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857747
Page 161 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020
11:06:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020
11:06:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-12-2020
11:06:53
(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-12-2020
11:06:53ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857748
Page 162 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-12-2020
11:06:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857749
Page 163 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020
11:06:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857750
Page 164 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020
14:54:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857751
Page 165 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-15-2020
16:54:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Sep-15-2020
16:50:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dNew
Information
Sep-15-2020
16:50:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/17/202
0New
Information
Sep-15-2020
12:49:20
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Query 2: Opened e-Diary: Per
diary records,
FEVER/PAIN
MED present
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857752
Page 166 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires on Last day
however
inform entered
with 'No' for
the same.
Please verify
and update. If
diary entered in
error, please
enter stop date
as last date of
diary or
consider
raising DCF to
correct diary
data.
Sep-14-2020
15:19:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Sep-14-2020
10:23:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
dChanged data
per query
Sep-02-2020
15:13:58
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Query 1: Opened e-Diary: Per
eDiary records,
FEVER/PAIN
MED is
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857753
Page 167 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires reported on
Last day
however the
last day in
inform is
entered as 'No'
for the same.
Please verify
and update.
Else, clarify.
Thanks
Sep-01-2020
14:56:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
RInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857754
Page 168 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
O
2.a Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857755
Page 169 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
U
E
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
O
2.b Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020
14:56:00ACV0PFEINFP6000  Data Entry:
Symptom:: HEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857756
Page 170 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresAD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NO
2.c Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857757
Page 171 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857758
Page 172 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857759
Page 173 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857760
Page 174 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-14-2020
10:44:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sympto
m::NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fev
er or syst
emic sym
ptoms pr
esent on
the last d
ay the Su
bject Dia
ry was co
mpleted?
:YES
Ongoing
?
NO
Stop
Date:
Aug
/17/
202
0Transcription
Error
Sep-14-2020
10:23:28
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINTranscription
Error
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857761
Page 175 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
Sep-01-2020
14:56:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sympto
m::NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fev
er or syst
emic sym
ptoms pr
esent on
the last d
ay the Su
bject Dia
ry was co
mpleted?
:YES
Ongoing
?
NO
Stop
Date:
Aug
/17/
202
0Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857762
Page 176 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.g Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-14-2020
10:44:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/17/2020Transcription
Error
Sep-14-2020
10:23:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOTranscription
Error
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857763
Page 177 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Stop Date:
Aug/17/2020
2.h
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857764
Page 178 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.h Symptom:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857765
Page 179 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires
5.a
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857766
Page 180 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5.b
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857767
Page 181 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857768
Page 182 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
14:56:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857769
Page 183 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
14:56:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020
14:56:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.9
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
14:56:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857770
Page 184 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.a Temperature:
Date Location User Value Reason
Sep-01-2020
14:56:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020
14:56:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
14:56:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857771
Page 185 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857772
Page 186 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
14:56:40
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857773
Page 187 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020
14:56:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857774
Page 188 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
14:56:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
14:56:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020
11:08:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-01-2020
15:49:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857775
Page 189 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Sep-01-2020
14:56:56
(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-01-2020
14:56:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020
11:08:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP273
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020
11:08:20ACV0PFEINFP6000  Data Entry:
BP2735Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857776
Page 190 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857777
Page 191 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020
14:57:23ACV0PFEINFP6000  Data Entry:
Sep/1/2020 12:29Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857778
Page 192 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
14:57:23ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857779
Page 193 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-01-2020
14:57:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857780
Page 194 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020
03:47:01
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-08-2020
16:59:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
dThe form in
question is
already
loaded. Thank
you.
Oct-07-2020
23:26:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Erica Weaver Query 1: Opened DM: Per CRF
guidelines, the
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination
(Visit 3 date).
As Visit 3 is
now reached,
please
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0857781
Page 195 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
complete the
EOT form
accordingly.
Oct-02-2020
10:04:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857782
Page 196 of 231
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857783
Page 197 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857784
Page 198 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.b Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857785
Page 199 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.c Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857786
Page 200 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.d Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857787
Page 201 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.e Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857788
Page 202 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.f Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857789
Page 203 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NO
2.g Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-02-2020
10:05:17ACV0PFEINFP6000  Data Entry:
Symptom:: NEWInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857790
Page 204 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresOR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857791
Page 205 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:N
OInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857792
Page 206 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857793
Page 207 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857794
Page 208 of 231
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Were injection
site reactions
present on the
last day the S
ubject Diary
was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
10:05:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857795
Page 209 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020
10:05:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020
10:05:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020
10:30:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-02-2020
10:05:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857796
Page 210 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Oct-02-2020
10:05:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020
10:30:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample I
D:BK6XN
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020
10:30:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BK6XN6Initial Entry
5.b
Date Location User Value Reason
Oct-02-2020
12:23:34
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I BPXJ5Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0857797
Page 211 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires D: R
5.b Sample ID
Date Location User Value Reason
Oct-02-2020
12:23:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXJ5RInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
13:10:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample I
D:BK6XN
LInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020
13:10:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BK6XNLInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0857798
Page 212 of 231
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
11:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0857799
Page 213 of 231
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
11:48:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
11:48:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
13:31:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
11:48:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0857800
Page 214 of 231
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Mar-12-2021
11:48:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
13:31:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BR22M
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
13:31:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR22MPInitial Entry
5.b
Date Location User Value Reason
Mar-12-2021
13:31:52
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I BRYF8Initial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857801
Page 215 of 231
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires D: 9
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
13:31:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYF89Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021
13:39:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRYF8
JInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
13:39:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYF8JInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0857802
Page 216 of 231
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-08-2020
14:14:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020
14:14:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020
14:14:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857803
Page 217 of 231
***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: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-07-2020
08:25:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196d6f287\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0857804
Page 218 of 231
***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, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311058 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020
0
…[truncated]