125742 S1 M5 CRF c4591001 1231 12311387

Document text

Page 1 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861381
Page 2 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/15/2020
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861382
Page 3 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311387]
2.Birth Date: /1996
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861383
Page 4 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861384
Page 5 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861385
Page 6 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861386
Page 7 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861387
Page 8 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861388
Page 9 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861389
Page 10 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861390
Page 11 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861391
Page 12 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bulimia]
Start Date: Apr/1/2015
Ongoing: NO
End Date:
Dec/10/2015
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861392
Page 13 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/15/2020
2.Weight: [82.15]
3.Unit: kg
4.Height: [158.0]
5.Unit: cm
6.Body Mass Index: [32.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861393
Page 14 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/15/2020
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:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861394
Page 15 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/15/2020
2.Randomization Number: [51509]
3.Randomization Group: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861395
Page 16 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP14H7]
5.bSample ID [BP14H8]
5.cSample ID [BP14H9]
5.dSample ID [BLCVW5]
5.eSample ID [BLCVW6]
5.fSample ID [BLCVW7]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861396
Page 17 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM844F]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861397
Page 18 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/15/2020 16:58
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861398
Page 19 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861399
Page 20 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861400
Page 21 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?YES
Ongoing?
NO
Stop Date:
Aug/21/2020
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861401
Page 22 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861402
Page 23 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861403
Page 24 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861404
Page 25 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
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:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861405
Page 26 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP2D38]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861406
Page 27 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 17:25
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861407
Page 28 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861408
Page 29 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861409
Page 30 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861410
Page 31 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861411
Page 32 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BPXHDM]
5.bSample ID [BLPHPX]
5.cSample ID [BLPHPY]
5.dSample ID [BLPHR7]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861412
Page 33 of 246
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861413
Page 34 of 246
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
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 [BNTYYN]
5.bSample ID [BNTYXX]
5.cSample ID [BR21CH]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861414
Page 35 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861415
Page 36 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861416
Page 37 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861417
Page 38 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861418
Page 39 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861419
Page 40 of 246
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861420
Page 41 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861421
Page 42 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861422
Page 43 of 246
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861423
Page 44 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861424
Page 45 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861425
Page 46 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861426
Page 47 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861427
Page 48 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861428
Page 49 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861429
Page 50 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861430
Page 51 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861431
Page 52 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861432
Page 53 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861433
Page 54 of 246
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861434
Page 55 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861435
Page 56 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861436
Page 57 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861437
Page 58 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861438
Page 59 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861439
Page 60 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861440
Page 61 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861441
Page 62 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861442
Page 63 of 246
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861443
Page 64 of 246
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR
otherwise not eligible
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861444
Page 65 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Drug Exposed Preg
nancy Nov/7/20
20 20:00 YES  Repeating
Pages
 2.ADVERSE
EVENT 2  Complicated Urinar
y Tract Infection Jan/4/202
1 08:00 NO
End Date Time:
Jan/18/2021 19:0
0
 Repeating
Pages
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861445
Page 66 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Drug Exposed Pregnancy]
4.Start Date Time: Nov/7/2020 20:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861446
Page 67 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861447
Page 68 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861448
Page 69 of 246
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Complicated Urinary Tract Infection]
4.Start Date Time: Jan/4/2021 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/18/2021 19:00
6.Toxicity Grade: 3
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861449
Page 70 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861450
Page 71 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
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[2021062460]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861451
Page 72 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861452
Page 73 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861453
Page 74 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861454
Page 75 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861455
Page 76 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861456
Page 77 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861457
Page 78 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861458
Page 79 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861459
Page 80 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861460
Page 81 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861461
Page 82 of 246
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861462
Page 83 of 246
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861463
Page 84 of 246
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861464
Page 85 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861465
Page 86 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861466
Page 87 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861467
Page 88 of 246
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861468
Page 89 of 246
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-09-2021 16:57:49 (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.
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861469
Page 90 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Dec-14-2020 13:10:58 (UTC-03:00)
City of Buenos AiresSantiago
CorradettiNot Applicable
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861470
Page 91 of 246
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-09-2021 16:57:49 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-09-2021 15:49:54 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-05-2021 13:49:15 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861471
Page 92 of 246
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-01-2021 13:52:51 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-25-2021 18:35:52 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861472
Page 93 of 246
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-25-2021 12:34:58 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo
Perez Marc Approved Jan-22-2021 17:35:37 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861473
Page 94 of 246
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-22-2021 12:33:47 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-20-2021 20:35:39 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861474
Page 95 of 246
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Dec-11-2020 11:41:35 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-22-2020 14:17:57 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861475
Page 96 of 246
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861476
Page 97 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-15-2020
16:05:53
(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-15-2020
16:05:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861477
Page 98 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-15-2020
16:06:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/15/2020Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861478
Page 99 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-15-2020
16:05:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311387Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-15-2020
16:05:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1996Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-15-2020
16:07:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-15-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861479
Page 100 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
16:07:11
(UTC-03:00) City
of Buenos AiresHISPANIC OR LA
TINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-15-2020
16:07:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861480
Page 101 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-16-2020
08:19:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861481
Page 102 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020
08:20:31
(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
of 18 and 55 ye
ars, inclusive,
65 and 85 year
s, inclusive, or
18 and 85 year
s, inclusive, at
randomization
(dependent upo
n study stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861482
Page 103 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partic
ipants between the ag
es of 18 and 55 years,
inclusive, 65 and 85
years, inclusive, or 1
8 and 85 years, inclus
ive, at randomization
(dependent upon studInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861483
Page 104 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
y stage)
1.a Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861484
Page 105 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n De
scri
ptio
n:Participants w
ho are willing
and able to co
mply with all s
cheduled visits
, vaccination p
lan, laboratory
tests, lifestyle
considerations,
and other stud
y procedures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861485
Page 106 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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 consideratio
ns, and other study pr
oceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861486
Page 107 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-16-2020
08:20:31
(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 exa
mination, and
clinical judgm
ent of the inves
tigator to be eli
gible for inclus
ion in the stud
yInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861487
Page 108 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN03A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861488
Page 109 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined b
y medical history, ph
ysical examination, a
nd clinical judgment
of the investigator to
be eligible for inclusi
on in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861489
Page 110 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n De
scri
ptio
n:Capable of giv
ing personal si
gned informed
consent, which
includes compl
iance with the
requirements a
nd restrictions
listed in the IC
D and in this p
rotocol
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861490
Page 111 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861491
Page 112 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving per
sonal signed informe
d consent, which incl
udes compliance with
the requirements and
restrictions listed in t
he ICD and in this pr
otocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861492
Page 113 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-16-2020
08:20:31
(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 act
ive suicidal ide
ation/behavior/
lab abnormalit
y that may incr
ease the risk of
study participa
tionInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861493
Page 114 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:NO
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psy
chiatric condition incl
. recent (within past y
ear) or active suicidal
ideation/behavior/labInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861494
Page 115 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
abnormality that may
increase the risk of st
udy participation
2.a Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:2Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861495
Page 116 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
Desc
riptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX02A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861496
Page 117 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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 (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861497
Page 118 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of sev
ere adverse rea
ction associate
d with a vaccin
e and/or severe
allergic reactio
n (eg, anaphyl
axis) to any co
mponent of the
study intervent
ion(s)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861498
Page 119 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861499
Page 120 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adv
erse reaction associat
ed with a vaccine and
/or severe allergic rea
ction (eg, anaphylaxi
s) to any component
of the study intervent
ion(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861500
Page 121 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descr
iption: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
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861501
Page 122 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medicatio
ns intended to preven
t COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861502
Page 123 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.e
Date Location User Value Reason
Aug-16-2020
08:20:31
(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 kno
wn or suspecte
d immunodefi
ciency, as dete
rmined by hist
ory and/or lab
oratory/physic
al examination
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861503
Page 124 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861504
Page 125 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromise
d individuals with kn
own or suspected im
munodeficiency, as d
etermined by history
and/or laboratory/phy
sical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861505
Page 126 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scri
ptio
n:Bleeding diath
esis or conditi
on associated
with prolonge
d bleeding that
would, in the o
pinion of the i
nvestigator, co
ntraindicate int
ramuscular inj
ection
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861506
Page 127 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861507
Page 128 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861508
Page 129 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or b
reastfeedi
ng
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX11A00Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861509
Page 130 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861510
Page 131 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.h
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber: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 on
ly):EX12A00Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861511
Page 132 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861512
Page 133 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.i
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressiv
e therapy, suc
h as cytotoxic
agents or syst
emic corticos
teroids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861513
Page 134 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or system
ic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861514
Page 135 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scri
ptio
n:Receipt of blo
od/plasma pro
ducts or immu
noglobulin, fro
m 60 days bef
ore study inter
vention admini
stration or plan
ned receipt thr
oughout the st
udy
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861515
Page 136 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX14A01
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861516
Page 137 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861517
Page 138 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861518
Page 139 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:16
Crite
rion
Desc
ripti
on:Participation i
n other studie
s involving st
udy interventi
on within 28
days prior to s
tudy entry an
d/or during st
udy participat
ion
Crite
rion
met?
:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861519
Page 140 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861520
Page 141 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861521
Page 142 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-16-2020
08:20:31
(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 stu
dy interventi
on containin
g lipid nanop
articles
Crite
rion
met?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861522
Page 143 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861523
Page 144 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(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-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861524
Page 145 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:22
Crit
erio
n D
escr
ipti
on:Investigator sit
e staff or Pfize
r employees di
rectly involved
in the conduct
of the study, si
te staff otherwi
se supervised
by the investig
ator, and their
respective fam
ily members
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861525
Page 146 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX21A01
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861526
Page 147 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees
directly involved in t
he conduct of the stu
dy, site staff otherwis
e supervised by the i
nvestigator, and their
respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861527
Page 148 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020
08:20:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861528
Page 149 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-16-2020
08:21:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-16-2020
08:21:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-16-2020
08:21:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861529
Page 150 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020
08:23:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Bulimia
Start Date: Apr/1/20
15
Ongoing: NO
End Dat
e:
Dec/1
0/201
5Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-16-2020
08:23:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861530
Page 151 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-16-2020
08:23:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BulimiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-16-2020
08:23:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Apr/1/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-16-2020
08:23:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/10/2015Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861531
Page 152 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
82.15Initial Entry
3. Unit:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861532
Page 153 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
158.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.9Initial Entry
7.a
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.0Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861533
Page 154 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861534
Page 155 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.a Temperature Location:
Date Location User Value Reason
Aug-16-2020
08:24:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861535
Page 156 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861536
Page 157 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-16-2020
08:24:56
(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:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861537
Page 158 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-16-2020
08:24:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861538
Page 159 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-16-2020
08:25:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-16-2020
08:25:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
51509Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861539
Page 160 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020
08:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020
08:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-16-2020
14:41:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-16-2020
08:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861540
Page 161 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Aug-16-2020
08:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-16-2020
14:41:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP14H
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-16-2020
14:41:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP14H7Initial Entry
5.b
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861541
Page 162 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
14:41:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP14H
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-16-2020
14:41:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP14H8Initial Entry
5.c
Date Location User Value Reason
Aug-16-2020
14:42:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP14H
9Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-16-2020
14:42:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP14H9Initial Entry
5.d
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861542
Page 163 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-18-2020
09:47:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCVW
5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020
09:47:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVW5Initial Entry
5.e
Date Location User Value Reason
Aug-18-2020
09:47:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCVW
6Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020
09:47:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVW6Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861543
Page 164 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.f
Date Location User Value Reason
Aug-18-2020
09:47:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCVW
7Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-18-2020
09:47:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVW7Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861544
Page 165 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020
08:25:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020
08:25:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-16-2020
09:48:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-16-2020
08:25:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861545
Page 166 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Aug-16-2020
08:25:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-16-2020
09:48:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM84
4FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-16-2020
09:48:45
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM844FInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861546
Page 167 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-16-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861547
Page 168 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
08:26:20
(UTC-03:00) City
of Buenos AiresAug/15/2020 16:58
5. Anatomical Location:
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861548
Page 169 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-16-2020
08:26:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861549
Page 170 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-16-2020
08:26:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861550
Page 171 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020
18:33:53
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861551
Page 172 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861552
Page 173 of 246
***Confidential***
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-11-2020
10:27:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sympto
m::FATIGU
E
Were fe
ver or s
ystemic
sympto
ms pres
ent on t
he last d
ay the S
ubject D
iary was
complet
ed?:YES
Ongoi
ng?
NO
Sto
p D
ate:
A
ug
/2
1/
20
20New
Information
Sep-04-2020
18:34:22ACV0PFEINFP6000  Data Entry:
Sympto FATIGInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861553
Page 174 of 246
***Confidential***
(UTC-03:00)
City of Buenos
Airesm:: UE
Were fev
er or sys
temic sy
mptoms
present
on the la
st day th
e Subjec
t Diary
was com
pleted?:YES
Ongoi
ng?
NO
Sto
p D
ate:
S
e
p/
4/
2
0
2
0
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
FDA-CBER-2021-5683-0861554
Page 175 of 246
***Confidential***
2.b Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-11-2020
10:27:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/21/202
0New
Information
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/4/2020Initial Entry
2.c
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861555
Page 176 of 246
***Confidential***
C
HE
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:N
O
2.c Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
L
SInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861556
Page 177 of 246
***Confidential***
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: V
O
MI
TI
N
GInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861557
Page 178 of 246
***Confidential***
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:N
O
2.e Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
R
R
H
E
AInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861558
Page 179 of 246
***Confidential***
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:N
O
2.f Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:
:NEW
OR
WOR
SEN
ED M
USC
LE P
AINInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861559
Page 180 of 246
***Confidential***
Were fever
or systemi
c symptom
s present o
n the last d
ay the Sub
ject Diary
was compl
eted?:NO
2.g Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSE
NED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR
WOR
SEN
ED J
OIN
T PAI
NInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861560
Page 181 of 246
***Confidential***
Were fever
or systemic
symptoms
present on
the last da
y the Subje
ct Diary w
as complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSE
NED 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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861561
Page 182 of 246
***Confidential***
18:34:22
(UTC-03:00)
City of Buenos
AiresLEFT
5.a
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::R
E
D
N
ES
S
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861562
Page 183 of 246
***Confidential***
5.b
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::S
W
EL
LI
NG
Were injectio
n site reactio
ns present on
the last day t
he Subject D
iary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
18:34:22
(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-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020
18:34:22ACV0PFEINFP6000  Data Entry:
Injection Si PAIInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861563
Page 184 of 246
***Confidential***
(UTC-03:00)
City of Buenos
Aireste Reaction:
:N A
T IN
JEC
TIO
N SI
TE
Were injecti
on site react
ions present
on the last
day the Sub
ject Diary
was comple
ted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTI
ON SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020
18:34:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861564
Page 185 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020
18:34:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020
18:34:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:36.3
Temperat
ure Unit:C
Temperat
ure Locat
ion::ORAL
CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861565
Page 186 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-04-2020
18:34:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020
18:34:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020
18:34:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020
18:34:33
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861566
Page 187 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861567
Page 188 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861568
Page 189 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-04-2020
18:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020
18:34:40
(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:
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861569
Page 190 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020
18:34:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861570
Page 191 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020
18:34:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
18:34:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
09:57:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-07-2020
05:15:38
(UTC-03:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861571
Page 192 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
18:34:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-04-2020
18:34:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020
09:57:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BP2D3
8Initial Entry
5.a Sample ID
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861572
Page 193 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-07-2020
09:57:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP2D38Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861573
Page 194 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861574
Page 195 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-04-2020
18:34:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020 17:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861575
Page 196 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-04-2020
18:34:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861576
Page 197 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-10-2020
09:07:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-09-2020
21:29:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered EOT form is
completed
Oct-05-2020
08:42:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to
update
missing EOT
visit or else
clarify. Thank
you.
Oct-02-2020
17:52:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861577
Page 198 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861578
Page 199 of 246
***Confidential***
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FATIGU
E
Were fever
or systemic
symptoms
present on t
he last day
the Subject
Diary was c
ompleted?:YES
Ongoi
ng?
NO
Sto
p D
ate:
Se
p/
10
/2
02
0Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861579
Page 200 of 246
***Confidential***
2.b Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/10/2020Initial Entry
2.c
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHEInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861580
Page 201 of 246
***Confidential***
Were fever
or systemic
symptoms
present on t
he last day
the Subject
Diary was c
ompleted?:YES
Ongoi
ng?
NO
Sto
p D
ate:
Se
p/
10
/2
02
0
2.c Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/10/2020Initial Entry
2.d
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861581
Page 202 of 246
***Confidential***
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
L
S
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861582
Page 203 of 246
***Confidential***
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NO
2.e Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861583
Page 204 of 246
***Confidential***
2.f Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic s
ymptoms pr
esent on the
last day the
Subject Diar
y was compl
eted?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861584
Page 205 of 246
***Confidential***
2.g Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED 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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861585
Page 206 of 246
***Confidential***
2.h Symptom:
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED 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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SSInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861586
Page 207 of 246
***Confidential***
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861587
Page 208 of 246
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
17:53:43
(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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N AT
INJE
CTI
ON
SITE
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was comp
leted?:NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861588
Page 209 of 246
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N 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
17:53:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861589
Page 210 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020
16:45:53
(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
16:45:53
(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
16:46:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-02-2020
16:45:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861590
Page 211 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Oct-02-2020
16:45:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020
16:46:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPXHD
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020
16:46:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXHDMInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861591
Page 212 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-02-2020
16:59:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BLPHP
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020
16:59:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLPHPXInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
17:00:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BLPHP
YInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020
17:00:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLPHPYInitial Entry
5.d
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861592
Page 213 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Oct-02-2020
17:21:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLPHR
7Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-02-2020
17:21:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLPHR7Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861593
Page 214 of 246
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021
13:52:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/1/2021Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861594
Page 215 of 246
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
13:53:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
13:53:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021
10:01:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-02-2021
06:16:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861595
Page 216 of 246
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
13:53:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
13:53:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021
10:01:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTYY
NInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861596
Page 217 of 246
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Mar-02-2021
10:01:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTYYNInitial Entry
5.b
Date Location User Value Reason
Mar-02-2021
10:30:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTYX
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-02-2021
10:30:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTYXXInitial Entry
5.c
Date Location User Value Reason
Mar-02-2021
11:30:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BR21C
HInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861597
Page 218 of 246
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Sample ID
Date Location User Value Reason
Mar-02-2021
11:30:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR21CHInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861598
Page 219 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020
21:28:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020
21:28:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020
21:28:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861599
Page 220 of 246
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-15-2021
13:34:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861600
Page 221 of 246
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-15-2021
13:34:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is NOT
willing to return fo
r Vaccination 3 OR
otherwise not eligi
bleInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861601
Page 222 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Dec-11-2020
11:41:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861602
Page 223 of 246
***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: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Jan-22-2021
12:33:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861603
Page 224 of 246
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Dec-11-2020
11:41:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-11-2020
11:41:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-15-2020
23:49:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-15-2020
10:40:15
(UTC-03:00)ACV0PFEINFP6000  Query 1: Answere
dSAE follow-up
form was sent.
No previous
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861604
Page 225 of 246
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Airespregnancies, no
ObGyn medical
history.
Contraception
method: barrier
method
(condom).
Dec-14-2020
11:30:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened CLINICAL -
please submit a
SAE safety
update with
contraception
information
and completing
the Parent
Pregnancy
section (on
prior
pregnancies).
Dec-11-2020
11:41:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Drug Exposed Pre
gnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-25-2020
20:21:10ACV0PFEINFP6000  Data Entry:
Nov/7/2020 20:00New
Information
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861605
Page 226 of 246
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City
of Buenos Aires
Dec-11-2020
11:41:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/1/2020 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-11-2020
11:41:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-15-2020
23:48:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Dec-14-2020
13:10:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Santiago
CorradettiData Entry:
Not ApplicableInitial Entry
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861606
Page 227 of 246
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-14-2020
13:10:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Dec-14-2020
13:10:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Santiago
CorradettiData Entry: Transcription
Error
Dec-14-2020
11:12:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened CLINICAL As
per CRF CG
8.50.2.5, the
toxicity grade
for “Exposure
During
Pregnancy” is
reported as Not
Applicable
Dec-11-2020
11:41:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861607
Page 228 of 246
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311387 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Dec-15-2020
23:47:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Dec-15-2020
10:37:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New
Information
Dec-15-2020
10:37:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-15-2020
10:37:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NONew
Information
Dec-14-2020
11:12:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened CLinical As
per CRF CG
8.50.2.5, an
“Exposure
During
Pregnancy” is
not an SAE
[despite using
090177e196ae2e93\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861608
Page 229 of 246
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
Histor
…[truncated]