125742 S1 M5 CRF c4591001 1231 12311205

Document text

Page 1 of 299
***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: 12311205 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
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859286
Page 2 of 299
***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: 12311205 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/14/2020
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859287
Page 3 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311205]
2.Birth Date: /1991
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859288
Page 4 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859289
Page 5 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination
plan, laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with
the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active suicidal
ideation/behavior/lab abnormality that may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859290
Page 6 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV),
or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859291
Page 7 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to study
entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2 mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the study,
site staff otherwise supervised by the investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859292
Page 8 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859293
Page 9 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859294
Page 10 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [54.5]
3.Unit: kg
4.Height: [154.0]
5.Unit: cm
6.Body Mass Index: [23.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859295
Page 11 of 299
***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: 12311205 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/14/2020
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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859296
Page 12 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [50147]
3.Randomization Group: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859297
Page 13 of 299
***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: 12311205 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/14/2020
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 [BLD3G4]
5.bSample ID [BLD3G3]
5.cSample ID [BLD3G2]
5.dSample ID [BM8H57]
5.eSample ID [BM8H56]
5 fSample ID [BM8H55]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859298
Page 14 of 299
***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: 12311205 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/14/2020
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 [BM8H4S]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859299
Page 15 of 299
***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: 12311205 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/14/2020 12:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859300
Page 16 of 299
***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: 12311205 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
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859301
Page 17 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859302
Page 18 of 299
***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: 12311205 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?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
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
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859303
Page 19 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859304
Page 20 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859305
Page 21 of 299
***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: 12311205 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/3/2020
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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859306
Page 22 of 299
***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: 12311205 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/3/2020
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 [BP273W]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859307
Page 23 of 299
***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: 12311205 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/3/2020 09:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859308
Page 24 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859309
Page 25 of 299
***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: 12311205 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?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
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
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859310
Page 26 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859311
Page 27 of 299
***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: 12311205 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/30/2020
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 [BPWDR4]
5.bSample ID [BJ5NCH]
5.cSample ID [BJ5NCK]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859312
Page 28 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859313
Page 29 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/16/2020
2.Date of First Symptom Started: Oct/14/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/22/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859314
Page 30 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.aSymptoms - Other Text: [Nasal Congestion]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859315
Page 31 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/16/202
0 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859316
Page 32 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/16/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859317
Page 33 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample collected by team physician.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859318
Page 34 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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:
Oct/16/2020
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 [BKVDNX]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859319
Page 35 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859320
Page 36 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859321
Page 37 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859322
Page 38 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859323
Page 39 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859324
Page 40 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859325
Page 41 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859326
Page 42 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859327
Page 43 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859328
Page 44 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859329
Page 45 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859330
Page 46 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859331
Page 47 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859332
Page 48 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859333
Page 49 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859334
Page 50 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859335
Page 51 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859336
Page 52 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859337
Page 53 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859338
Page 54 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859339
Page 55 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859340
Page 56 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/1/2020
2.Date of First Symptom Started: Nov/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/14/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859341
Page 57 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.aSymptoms - Other Text: [Asthenia]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859342
Page 58 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/1/2020
 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
 2.Dec/3/2020
 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859343
Page 59 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/1/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859344
Page 60 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/3/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859345
Page 61 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Sample collected by a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859346
Page 62 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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:
Dec/1/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW87P]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859347
Page 63 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859348
Page 64 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859349
Page 65 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859350
Page 66 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 Disease]
Date of Diagnosis:
Dec/3/2020
3.Toxicity Grade: 1
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859351
Page 67 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859352
Page 68 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859353
Page 69 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859354
Page 70 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859355
Page 71 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859356
Page 72 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859357
Page 73 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859358
Page 74 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859359
Page 75 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859360
Page 76 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859361
Page 77 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859362
Page 78 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859363
Page 79 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859364
Page 80 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859365
Page 81 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859366
Page 82 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859367
Page 83 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/26/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/26/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859368
Page 84 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/26/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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:
Nov/26/2020
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 [BRVMHF]
5.bSample ID [BRVMGZ]
5.cSample ID [BPWSPX]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859369
Page 85 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B1
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859370
Page 86 of 299
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 2 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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:
Jan/29/2021
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 [BS423F]
5.bSample ID [BPWFT7]
5.cSample ID [BRYWPN]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859371
Page 87 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859372
Page 88 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859373
Page 89 of 299
***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: 12311205 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/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859374
Page 90 of 299
***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: 12311205 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: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859375
Page 91 of 299
***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: 12311205 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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859376
Page 92 of 299
***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: 12311205 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 [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859377
Page 93 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859378
Page 94 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859379
Page 95 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859380
Page 96 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859381
Page 97 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859382
Page 98 of 299
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859383
Page 99 of 299
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859384
Page 100 of 299
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859385
Page 101 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859386
Page 102 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/26/2021
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859387
Page 103 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859388
Page 104 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859389
Page 105 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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: Feb/26/2021
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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859390
Page 106 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12311205 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:
Feb/26/2021
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 [BRZ1NN]
5.bSample ID [BRZ1PH]
5.cSample ID [BR1ZXC]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859391
Page 107 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BR1ZXC ]
5.bSample ID [BR201H]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859392
Page 108 of 299
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/26/2021 14:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859393
Page 109 of 299
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/17/2021
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859394
Page 110 of 299
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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: Mar/17/2021
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:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859395
Page 111 of 299
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12311205 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:
Mar/17/2021
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 [BR1LRG]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859396
Page 112 of 299
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/17/2021 11:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859397
Page 113 of 299
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859398
Page 114 of 299
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859399
Page 115 of 299
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859400
Page 116 of 299
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859401
Page 117 of 299
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859402
Page 118 of 299
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859403
Page 119 of 299
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859404
Page 120 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  Left arm olecranon fract
ure Sep/17/2020 20:
00 NO
End Date Time:
Feb/12/2021 11:00
 Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859405
Page 121 of 299
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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)[Left arm olecranon fracture]
4.Start Date Time: Sep/17/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 11:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Car crash]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859406
Page 122 of 299
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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? YES
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[2020412507]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859407
Page 123 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859408
Page 124 of 299
***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: 12311205 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[ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859409
Page 125 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859410
Page 126 of 299
***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: 12311205 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: //
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859411
Page 127 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859412
Page 128 of 299
***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: 12311205 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?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859413
Page 129 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859414
Page 130 of 299
***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: 12311205 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?
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859415
Page 131 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859416
Page 132 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859417
Page 133 of 299
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859418
Page 134 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859419
Page 135 of 299
***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: 12311205 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: [ ]
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859420
Page 136 of 299
***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: 12311205 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/30/2020
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859421
Page 137 of 299
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0859422
Page 138 of 299
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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-17-2021 16:39:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859423
Page 139 of 299
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-14-2020 14:01:43 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0859424
Page 140 of 299
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Dec/01/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Dec-16-2020 11:04:48 (UTC-03:00) City of Buenos
AiresNALT unknown.
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0859425
Page 141 of 299
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormFeb-26-2021 16:08:18 (UTC-03:00) City of Buenos
AiresMartina Davalli Not Applicable
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0859426
Page 142 of 299
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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-17-2021 16:39:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-17-2021 16:27:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-17-2021 16:22:59 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-17-2021 14:29:24 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-02-2021 17:49:10 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859427
Page 143 of 299
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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 Feb-25-2021 10:23:53 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-18-2021 13:40:29 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-12-2021 16:58:11 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Feb-04-2021 18:17:44 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859428
Page 144 of 299
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
 N/A Feb-01-2021 12:25:07 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo Perez
Marc Approved Feb-01-2021 12:24:33 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-29-2021 14:40:36 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Vanesa Fainboim  Approved Jan-20-2021 18:54:26 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, VanesaFainboim, 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-05-2020 11:34:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-26-2020 23:25:07 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859429
Page 145 of 299
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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 Nov-26-2020 16:26:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-26-2020 15:54:48 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-26-2020 15:40:07 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-26-2020 14:36:27 (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.
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859430
Page 146 of 299
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
 N/A Nov-26-2020 09:37:19 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Oct-31-2020 13:12:32 (UTC-03:00) City of Buenos
AiresBOOK Signed
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.
Alan Colombo  N/A Oct-30-2020 17:48:23 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Oct-29-2020 18:10:19 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-29-2020 08:20:33 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Oct-28-2020 19:30:56 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859431
Page 147 of 299
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311205 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.
 N/A Oct-28-2020 11:39:06 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Oct-27-2020 10:43:50 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-24-2020 11:36:26 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-23-2020 18:14:25 (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.
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859432
Page 148 of 299
***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: 12311205 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-14-2020 13:59:21
(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-14-2020 13:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859433
Page 149 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 13:59:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859434
Page 150 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 11:30:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311205Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 11:30:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1991Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 13:59:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 13:59:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 13:59:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859435
Page 151 of 299
***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: 12311205 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-14-2020 14:00:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859436
Page 152 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants be
tween the ages of 18 and 55 y
ears, inclusive, 65 and 85 year
s, inclusive, or 18 and 85 year
s, inclusive, at randomization
(dependent upon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Male or female participants between th
e ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 ye
ars, inclusive, at randomization (depen
dent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859437
Page 153 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-14-2020 14:01:17
(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-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Desc
ription:Participants who are willing a
nd able to comply with all sc
heduled visits, vaccination pl
an, laboratory tests, lifestyle
considerations, and other stud
y procedures
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN02A00Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859438
Page 154 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able to
comply with all scheduled visits, vacci
nation plan, laboratory tests, lifestyle c
onsiderations, and other study procedur
esInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inves
tigator to be eligible for inclu
sion in the studyInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859439
Page 155 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determine
d by medical history, physical examinat
ion, and clinical judgment of the investi
gator to be eligible for inclusion in the
studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Inclusio
n Num4Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859440
Page 156 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
ber:
Criteri
on Desc
ription:Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restrictio
ns listed in the ICD and in thi
s protocol
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed infor
med consent, which includes complian
ce with the requirements and restriction
s listed in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859441
Page 157 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.a
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal id
eation/behavior/lab abnormali
ty that may increase the risk o
f study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormal
ity that may increase the risk of study p
articipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859442
Page 158 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency virus
(HIV), hepatitis C virus (H
CV), or hepatitis B virus (H
BV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859443
Page 159 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Known infection with human immunod
eficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)
Criteri
on met
?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859444
Page 160 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID: (
For Pfi
zer use
only):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction asso
ciated with a vaccine and/or severe alle
rgic reaction (eg, anaphylaxis) to any c
omponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859445
Page 161 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion met
?:NO
Criterion ID: (
For Pfizer use
only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(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-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:8Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859446
Page 162 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinatio
n
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency,
as determined by history and/or laborat
ory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859447
Page 163 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:10
Criterio
n Descr
iption:Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular inj
ection
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859448
Page 164 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associat
ed with prolonged bleeding that would,
in the opinion of the investigator, contr
aindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Numb
er:11
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859449
Page 165 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeed
ingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(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-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:12
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859450
Page 166 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronavi
rus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(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-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive imm
unosuppressive therapy, su
ch as cytotoxic agents or s
ystemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859451
Page 167 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppressi
ve therapy, such as cytotoxic agents or
systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:15
Criterio
n Descr
iption:Receipt of blood/plasma pro
ducts or immunoglobulin, fro
m 60 days before study inter
vention administration or pla
nned receipt throughout the s
tudy
Criterio
n met?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859452
Page 168 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stu
dy intervention administration or plann
ed receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859453
Page 169 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studie
s involving study interventi
on within 28 days prior to st
udy entry and/or during stu
dy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859454
Page 170 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involving
study intervention within 28 days prior
to study entry and/or during study parti
cipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in o
ther studies involving stud
y intervention containing l
ipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX16A01Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859455
Page 171 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studies i
nvolving study intervention containing
lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfize
r employees directly involved
in the conduct of the study, si
te staff otherwise supervised
by the investigator, and their r
espective family members
Criteri
on met
?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859456
Page 172 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employ
ees directly involved in the conduct of
the study, site staff otherwise supervise
d by the investigator, and their respecti
ve family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-14-2020 14:01:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859457
Page 173 of 299
***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: 12311205 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-14-2020 14:01:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 14:01:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 14:01:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859458
Page 174 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
54.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
154.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.0Initial Entry
7.a
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859459
Page 175 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 14:02:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859460
Page 176 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859461
Page 177 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-14-2020 14:02:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859462
Page 178 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 14:02:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 14:02:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
50147Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859463
Page 179 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 14:02:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 14:02:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-15-2020 14:31:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 14:02:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-14-2020 14:02:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-15-2020 14:31:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD3G4Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859464
Page 180 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 14:31:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLD3G4Initial Entry
5.b
Date Location User Value Reason
Aug-15-2020 14:31:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD3G3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-15-2020 14:31:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLD3G3Initial Entry
5.c
Date Location User Value Reason
Aug-15-2020 14:32:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD3G2Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-15-2020 14:32:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BLD3G2Initial Entry
5.d
Date Location User Value Reason
Aug-15-2020 14:33:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM8H57Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-15-2020 14:33:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM8H57Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859465
Page 181 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.e
Date Location User Value Reason
Aug-15-2020 14:33:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM8H56Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-15-2020 14:33:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM8H56Initial Entry
5.f
Date Location User Value Reason
Aug-15-2020 14:33:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM8H55Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-15-2020 14:33:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM8H55Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859466
Page 182 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 14:02:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 14:02:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-15-2020 08:42:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 14:02:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-14-2020 14:02:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-15-2020 08:42:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BM8H4SInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859467
Page 183 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 08:42:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM8H4SInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859468
Page 184 of 299
***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: 12311205 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-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/14/2020 12:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859469
Page 185 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-14-2020 14:03:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859470
Page 186 of 299
***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: 12311205 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-14-2020 14:03:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859471
Page 187 of 299
***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: 12311205 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-03-2020 10:46:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859472
Page 188 of 299
***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: 12311205 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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859473
Page 189 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859474
Page 190 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859475
Page 191 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859476
Page 192 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859477
Page 193 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Symptom:
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENED 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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RED
NES
S
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859478
Page 194 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 10:46:46
(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-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859479
Page 195 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 10:46:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859480
Page 196 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 10:47:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2.a
Date Location User Value Reason
Sep-03-2020 10:47:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 10:47:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-03-2020 10:47:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-03-2020 10:47:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 10:47:22
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859481
Page 197 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0859482
Page 198 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859483
Page 199 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-03-2020 10:47:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859484
Page 200 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 10:47:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 10:47:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 11:37:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 10:47:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-03-2020 10:47:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 11:37:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP273WInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859485
Page 201 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-03-2020 11:37:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP273WInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859486
Page 202 of 299
***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: 12311205 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-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/3/2020 09:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859487
Page 203 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-03-2020 10:48:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859488
Page 204 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-02-2020
12:57:39
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-02-2020
10:40:08
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredOriginal value is correct
Nov-02-2020
07:22:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 22 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Oct-30-2020
18:57:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Oct/3
0/202
0Initial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0859489
Page 205 of 299
***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: 12311205 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-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-30-2020 18:59:24
(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-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
EInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859490
Page 206 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NO
2.b Symptom:
Date Location User Value Reason
Oct-30-2020 18:59:24
(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-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0859491
Page 207 of 299
***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: 12311205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Symptom:
Date Location User Value Reason
Oct-30-2020 18:59:24
(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-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-30-2020 18:59:24
(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-30-2020 18:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae2e44\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b
…[truncated]