Document text
Page 1 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860068
Page 2 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/15/2020
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860069
Page 3 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311295]
2.Birth Date: /1982
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860070
Page 4 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860071
Page 5 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860072
Page 6 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860073
Page 7 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860074
Page 8 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860075
Page 9 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860076
Page 10 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraine]
Start Date: Jan/1/2001
Ongoing: YES
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860077
Page 11 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/15/2020
2.Weight: [108.0]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [35.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860078
Page 12 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860079
Page 13 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/15/2020
2.Randomization Number: [51154]
3.Randomization Group: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860080
Page 14 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLCV60]
5.bSample ID [BLCV5Z]
5.cSample ID [BLCV5Y]
5.dSample ID [BM8396]
5.eSample ID [BM8397]
5.fSample ID [BM8398]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860081
Page 15 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM83B7]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860082
Page 16 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/15/2020 11:03
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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860083
Page 17 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860084
Page 18 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860085
Page 19 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860086
Page 20 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860087
Page 21 of 296
***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: 12311295 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: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860088
Page 22 of 296
***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: 12311295 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:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860089
Page 23 of 296
***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: 12311295 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 [BP274G]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860090
Page 24 of 296
***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: 12311295 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 09:35
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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860091
Page 25 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860092
Page 26 of 296
***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: 12311295 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?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860093
Page 27 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
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?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860094
Page 28 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/10/2020
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860095
Page 29 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXHDH]
5.bSample ID [BLPHPP]
5.cSample ID [BLPHR3]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860096
Page 30 of 296
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860097
Page 31 of 296
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
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 [BRYF65]
5.bSample ID [BR1P5T]
5.cSample ID [BRYF52]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860098
Page 32 of 296
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860099
Page 33 of 296
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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 [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860100
Page 34 of 296
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860101
Page 35 of 296
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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 [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860102
Page 36 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860103
Page 37 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/6/2020
2.Date of First Symptom Started: Oct/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/15/2020
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? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860104
Page 38 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860105
Page 39 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/6/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860106
Page 40 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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/6/2020
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: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860107
Page 41 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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 [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860108
Page 42 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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/6/2020
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 [BP1V46]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860109
Page 43 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860110
Page 44 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860111
Page 45 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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?
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860112
Page 46 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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: 1
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860113
Page 47 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860114
Page 48 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860115
Page 49 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for La
b TestVendor N
ameCollection
Date:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860116
Page 50 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860117
Page 51 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860118
Page 52 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860119
Page 53 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860120
Page 54 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860121
Page 55 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860122
Page 56 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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 % [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860123
Page 57 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860124
Page 58 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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):[ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860125
Page 59 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860126
Page 60 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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?
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860127
Page 61 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860128
Page 62 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/06/2020Form: 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: 12311295 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:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860129
Page 63 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/05/2020Form: 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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860130
Page 64 of 296
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/05/2020Form: 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: 12311295 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/5/2020
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 [BPWDSC]
5.bSample ID [BJ5NKH]
5.cSample ID [BJ5NKY]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860131
Page 65 of 296
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/05/2020Form: 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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/5/2020
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860132
Page 66 of 296
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/05/2020Form: UNPLANNED VISIT
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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860133
Page 67 of 296
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/05/2020Form: CONTACT OUTCOME - UNPLANNED
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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/5/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860134
Page 68 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860135
Page 69 of 296
***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: 12311295 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: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860136
Page 70 of 296
***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: 12311295 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:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860137
Page 71 of 296
***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: 12311295 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 [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860138
Page 72 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860139
Page 73 of 296
***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: 12311295 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:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860140
Page 74 of 296
***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: 12311295 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:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860141
Page 75 of 296
***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: 12311295 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?
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860142
Page 76 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860143
Page 77 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860144
Page 78 of 296
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860145
Page 79 of 296
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/3/2021
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860146
Page 80 of 296
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12311295 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/3/2021
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 [BPWC6J]
5.bSample ID [BS43G7]
5.cSample ID [BS43FT]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860147
Page 81 of 296
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12311295 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/3/2021
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 [BPWCTJ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860148
Page 82 of 296
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/16/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860149
Page 83 of 296
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/16/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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/16/2021
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 [BR1N6Y]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860150
Page 84 of 296
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860151
Page 85 of 296
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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 [BP1Z3Z]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860152
Page 86 of 296
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK6
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860153
Page 87 of 296
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 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/10/2021
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 [BR21Z8]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860154
Page 88 of 296
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860155
Page 89 of 296
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860156
Page 90 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1. ADVERSE E
VENT 1 Left axillary ade
nopathy Sep/5/2020
09:00 NO
End Date Time:
Sep/20/2020 12:00
Repeating
Pages
2. DELETED ADVERSE E
VENT 2 Diarrhea Oct/4/2020
10:00 NO
End Date Time:
Oct/4/2020 22:00
Repeating
Pages
3. ADVERSE E
VENT 3 Tension headach
e Oct/5/2020
10:00 NO
End Date Time:
Oct/15/2020 12:00
Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860157
Page 91 of 296
***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: 12311295 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 axillary adenopathy]
4.Start Date Time: Sep/5/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/20/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860158
Page 92 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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[ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860159
Page 93 of 296
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diarrhea]
4.Start Date Time: Oct/4/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 22:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860160
Page 94 of 296
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860161
Page 95 of 296
***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: 12311295 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Tension headache]
4.Start Date Time: Oct/5/2020 10:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/15/2020 12:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860162
Page 96 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[tensional]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860163
Page 97 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Catego
ryMedication E
rrorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860164
Page 98 of 296
***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: 12311295 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[ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860165
Page 99 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860166
Page 100 of 296
***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: 12311295 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: //
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860167
Page 101 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860168
Page 102 of 296
***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: 12311295 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?
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860169
Page 103 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860170
Page 104 of 296
***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: 12311295 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?
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860171
Page 105 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860172
Page 106 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860173
Page 107 of 296
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860174
Page 108 of 296
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860175
Page 109 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/10/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860176
Page 110 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860177
Page 111 of 296
***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: 12311295 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: [ ]
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860178
Page 112 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860179
Page 113 of 296
***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: 12311295 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
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860180
Page 114 of 296
***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: 12311295 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
Carola Baldoni Approved Mar-15-2021 16:19:28 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CarolaBaldoni, 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.
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860181
Page 115 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormOct-22-2020 18:41:50 (UTC-03:00) City of
Buenos AiresMartina Davalli
FormAug-15-2020 12:44:23 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860182
Page 116 of 296
***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: 12311295 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
Carola Baldoni Approved Mar-15-2021 16:19:28 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CarolaBaldoni, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina
Davalli N/A Mar-10-2021 16:06:16 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-03-2021 15:07:41 (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-02-2021 18:27:20 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860183
Page 117 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
N/A
Approved Feb-18-2021 13:52:19 (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-16-2021 18:52:13 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-04-2021 21:09:42 (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-03-2021 17:15:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-06-2020 18:43:59 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860184
Page 118 of 296
***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: 12311295 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-06-2020 10:21:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-05-2020 15:51:24 (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-05-2020 10:49:38 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-04-2020 11:26:43 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860185
Page 119 of 296
***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: 12311295 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.
Martina
Davalli N/A Nov-03-2020 19:31:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-02-2020 14:33:16 (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-01-2020 11:25:35 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-23-2020 17:13:16 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b)
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860186
Page 120 of 296
***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: 12311295 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-23-2020 11:57:18 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-22-2020 19:01:25 (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-22-2020 11:29:09 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-22-2020 09:46:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860187
Page 121 of 296
***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: 12311295 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-14-2020 13:16:22 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-14-2020 10:31:44 (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-14-2020 08:20:59 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-13-2020 20:52:40 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860188
Page 122 of 296
***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: 12311295 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.
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860189
Page 123 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-15-2020 12:42:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-15-2020 12:42:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860190
Page 124 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-15-2020 12:42:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/15/2020Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860191
Page 125 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-15-2020 09:42:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12311295Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-15-2020 09:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-15-2020 12:43:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-15-2020 12:43:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-15-2020 12:43:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860192
Page 126 of 296
***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: 12311295 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-15-2020 12:43:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/15/2020Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860193
Page 127 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participa
nts between the ages of
18 and 55 years, inclusiv
e, 65 and 85 years, inclu
sive, or 18 and 85 years,
inclusive, at randomizati
on (dependent upon stud
y stage)
Criter
ion m
et?:YES
Criter
ion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860194
Page 128 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants betw
een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion Nu
mber:2
Criter
ion De
scripti
on:Participants who are wil
ling and able to comply
with all scheduled visits
, vaccination plan, labor
atory tests, lifestyle con
siderations, and other st
udy procedures
Criter
ion me
t?:YESInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860195
Page 129 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and
able to comply with all schedule
d visits, vaccination plan, laborat
ory tests, lifestyle considerations
, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860196
Page 130 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umber
:3
Criter
ion De
scripti
on:Healthy participants wh
o are determined by me
dical history, physical e
xamination, and clinical
judgment of the investig
ator to be eligible for in
clusion in the study
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860197
Page 131 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are det
ermined by medical history, phys
ical examination, and clinical jud
gment of the investigator to be el
igible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860198
Page 132 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Capable of giving perso
nal signed informed con
sent, which includes co
mpliance with the requir
ements and restrictions l
isted in the ICD and in t
his protocol
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860199
Page 133 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signe
d informed consent, which inclu
des compliance with the require
ments and restrictions listed in th
e ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860200
Page 134 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Other medical or psychi
atric condition incl. rece
nt (within past year) or a
ctive suicidal ideation/b
ehavior/lab abnormality
that may increase the ris
k of study participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric con
dition incl. recent (within past ye
ar) or active suicidal ideation/be
havior/lab abnormality that may
increase the risk of study particip
ationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860201
Page 135 of 296
***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: 12311295 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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descr
iption:Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860202
Page 136 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human im
munodeficiency virus (HIV), hep
atitis C virus (HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860203
Page 137 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:History of severe advers
e reaction associated wit
h a vaccine and/or sever
e allergic reaction (eg, a
naphylaxis) to any com
ponent of the study inter
vention(s)
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860204
Page 138 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reactio
n associated with a vaccine and/
or severe allergic reaction (eg, an
aphylaxis) to any component of t
he study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medica
tions intended to p
revent COVID-19Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860205
Page 139 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended
to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Exclus8Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860206
Page 140 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires ion Nu
mber:
Criteri
on Des
criptio
n:Immunocompromised i
ndividuals with known
or suspected immunode
ficiency, as determined
by history and/or labora
tory/physical examinati
on
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860207
Page 141 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individual
s with known or suspected immu
nodeficiency, as determined by h
istory and/or laboratory/physical
examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860208
Page 142 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Bleeding diathesis or co
ndition associated with
prolonged bleeding that
would, in the opinion of
the investigator, contrai
ndicate intramuscular in
jection
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860209
Page 143 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition a
ssociated with prolonged bleedin
g that would, in the opinion of th
e investigator, contraindicate intr
amuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeedingInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860210
Page 144 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or brea
stfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
Exclusion N 12Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860211
Page 145 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires umber:
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccine
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any co
ronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860212
Page 146 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemic
corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX13A01Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860213
Page 147 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosu
ppressive therapy, such as cytoto
xic agents or systemic corticoster
oidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860214
Page 148 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Receipt of blood/plasm
a products or immunogl
obulin, from 60 days be
fore study intervention
administration or plann
ed receipt throughout th
e study
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860215
Page 149 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma product
s or immunoglobulin, from 60 da
ys before study intervention adm
inistration or planned receipt thr
oughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860216
Page 150 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other s
tudies involving study
intervention within 28
days prior to study entr
y and/or during study
participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX15A01Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860217
Page 151 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies inv
olving study intervention within
28 days prior to study entry and/
or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860218
Page 152 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860219
Page 153 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other st
udies involving study interventio
n containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860220
Page 154 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees directl
y involved in the condu
ct of the study, site staff
otherwise supervised by
the investigator, and thei
r respective family mem
bers
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860221
Page 155 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in th
e conduct of the study, site staff
otherwise supervised by the inve
stigator, and their respective fam
ily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-15-2020 12:43:59
(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-15-2020 12:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860222
Page 156 of 296
***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: 12311295 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-15-2020 12:44:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-15-2020 12:44:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-15-2020 12:44:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860223
Page 157 of 296
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Nov-06-2020 11:47:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Number: 1
Medical History Te
rm:Migraine
Start Date: Jan/1/200
1
Ongoing: YESNew Information
Nov-05-2020 12:38:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Migraine
Start Date: UNK/UNK/
2001
Ongoing: YESTranscription Error
Nov-05-2020 12:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Migraine
Start Date: UNK/UNK/20
01
Ongoing: NO
End Date:
UNK/UNK
/2001Changed
Information
Nov-05-2020 12:37:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:HeadacheTranscription Error
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860224
Page 158 of 296
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Start Date: UNK/UNK/20
01
Ongoing: NO
End Date:
UNK/UNK
/2001
Nov-05-2020 12:36:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Headache
Start Date: UNK/UNK/20
06
Ongoing: NO
End Date:
UNK/UNK
/2001Changed
Information
Oct-23-2020 11:57:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Headache
Start Date: UNK/UNK/20
06
Ongoing: NO
End Date:
UNK/UNK
/2015New Information
Oct-22-2020 18:42:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Headache
Start Date: UNK/UNK/
2006
Ongoing: YESInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860225
Page 159 of 296
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.a Line/MH Number:
Date Location User Value Reason
Oct-22-2020 18:42:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-05-2020 12:37:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MigraineChanged
Information
Oct-22-2020 18:42:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
HeadacheInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-06-2020 11:47:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/1/2001New Information
Nov-05-2020 12:37:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Transcription Error
Oct-22-2020 18:42:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
UNK/UNK/2006Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-05-2020 12:38:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESTranscription Error
Nov-05-2020 12:37:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860226
Page 160 of 296
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nov-05-2020 12:36:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Term Headache
End Date is prior to
Start Date.
Nov-05-2020 12:36:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Changed
Information
Oct-23-2020 11:57:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015New Information
Oct-22-2020 18:42:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860227
Page 161 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
108.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860228
Page 162 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.7Initial Entry
7.a
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.5
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860229
Page 163 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 12:45:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860230
Page 164 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860231
Page 165 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-15-2020 12:46:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860232
Page 166 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-15-2020 12:46:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-15-2020 12:46:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
51154Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860233
Page 167 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-15-2020 12:46:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-15-2020 12:46:48
(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 14:53:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-15-2020 12:46:48
(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-15-2020 12:46:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-15-2020 14:53:15
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860234
Page 168 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Sample ID: BLCV60
5.a Sample ID
Date Location User Value Reason
Aug-15-2020 14:53:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCV60Initial Entry
5.b
Date Location User Value Reason
Aug-15-2020 14:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCV5ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-15-2020 14:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCV5ZInitial Entry
5.c
Date Location User Value Reason
Aug-15-2020 14:53:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCV5YInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-15-2020 14:53:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCV5YInitial Entry
5.d
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860235
Page 169 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 16:04:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BM8396Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-15-2020 16:04:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BM8396Initial Entry
5.e
Date Location User Value Reason
Aug-15-2020 16:05:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BM8397Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-15-2020 16:05:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BM8397Initial Entry
5.f
Date Location User Value Reason
Aug-15-2020 16:05:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BM8398Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-15-2020 16:05:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BM8398Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860236
Page 170 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-15-2020 12:47:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-15-2020 12:47:05
(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 14:39:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-15-2020 12:47:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-15-2020 12:47:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-15-2020 14:39:30
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860237
Page 171 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Sample ID: BM83B7
5.a Sample ID
Date Location User Value Reason
Aug-15-2020 14:39:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BM83B7Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860238
Page 172 of 296
***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: 12311295 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-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/15/2020 11:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860239
Page 173 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-15-2020 12:47:33
(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-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-15-2020 12:47:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860240
Page 174 of 296
***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: 12311295 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-15-2020 12:48:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860241
Page 175 of 296
***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: 12311295 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 12:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860242
Page 176 of 296
***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: 12311295 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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860243
Page 177 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860244
Page 178 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860245
Page 179 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860246
Page 180 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860247
Page 181 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860248
Page 182 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Symptom:
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial 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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860249
Page 183 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860250
Page 184 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c
Date Location User Value Reason
Sep-03-2020 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020 12:06:03
(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 12:06:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860251
Page 185 of 296
***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: 12311295 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 12:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/3/2020Initial Entry
2.a
Date Location User Value Reason
Sep-03-2020 12:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.2
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 12:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-03-2020 12:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-03-2020 12:06:41
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860252
Page 186 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
2.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 12:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0860253
Page 187 of 296
***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: 12311295 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 12:06:56
(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 12:06:56
(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 12:06:56
(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 12:06:56
(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 12:06:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860254
Page 188 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-03-2020 12:06:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020 12:06:56
(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 12:06:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-03-2020 12:06:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860255
Page 189 of 296
***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: 12311295 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 11:41:06
(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 11:41:06
(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 11:41:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-03-2020 11:41:06
(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 11:41:23
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860256
Page 190 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Sample ID: BP274G
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 11:41:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP274GInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860257
Page 191 of 296
***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: 12311295 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 12:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 12:07:56
(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 12:07:56
(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 12:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/3/2020 09:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 12:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860258
Page 192 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-03-2020 12:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 12:07:56
(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 12:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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 12:07:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860259
Page 193 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-11-2020 21:44:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Erica Weaver Query 1: Closed Response satisfies
query
Oct-11-2020 10:22:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered COV ILL visit
form is loaded w/
date oct 6. thank
you
Oct-08-2020 13:42:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Erica Weaver Query 2: Closed Response satisfies
query
Oct-08-2020 12:30:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered EOT form
completed
Oct-07-2020 23:43:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Erica Weaver Query 2: Opened DM: Per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination (Visit 3
date). As Visit 3 is
now reached,
please complete the
EOT form
accordingly.
Oct-07-2020 08:07:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860260
Page 194 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
the following?” for
the COVID-19
symptoms or
diagnosis on
04OCT2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Oct-05-2020 08:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860261
Page 195 of 296
***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: 12311295 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-15-2020 03:29:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Data updated
Oct-14-2020 08:20:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/10/2020Transcription Error
Oct-13-2020 20:01:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered No fever or pain
medication was
given on the last day
you completed the
e-diary
Oct-13-2020 16:26:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Erica Weaver Query 1: Reissued:Opened If they had
fever/pain med as
YES on 8/Sep,
please enter a stop
date for that entry
here.
Oct-13-2020 15:08:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered the last day the
patient filled the
diary was 8
Sep2020, she forgot
to fill the diary on 9
Sep2020. On 10
Sep2020 she refered
no sintoms by a
phonecall
Oct-13-2020 03:14:08 ACV0PFEINFP6000 Query 1: Reissued:Opened eDiary RQ 2:
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0860262
Page 196 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresThanks for response.
Per CCG, If
'symptom/reaction
/medication' in
e-diary was entered
in error on the last
day, please consider
updating 'Yes' in
inform with stop
date as last date of
e-diary.
Oct-12-2020 12:37:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The last day the
patient forgot to fill
in the diary (8
Sep2020),on 10 sep
refer no sintoms
Oct-09-2020 15:06:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened e-Diary: Per eDiary
records,
FEVER/PAIN MED
is reported on Last
day (08Sep2020)
however inform is
entered with 'No' for
the same. Please
verify and update as
appropriate.
Oct-09-2020 12:56:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Based on visit 3
medical records No
medications to treat
fever or pain were
administered on
latests days at the
e-diary. Thank you
Oct-06-2020 09:34:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened eDiary: Per diary
records, Day 6 is the
last day reported on
08Sep20 &
FEVER/PAIN MED
present on Last day
however inform is
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (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-2021-5683-0860263
Page 197 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
entered with 'No' for
the same. Please
verify and update. If
diary entered in
error, please enter
stop date as last date
of diary.
Oct-05-2020 08:05:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-05-2020 08:05:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-05-2020 08:05:24
(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-05-2020 08:05:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860264
Page 198 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-05-2020 08:05:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Oct-05-2020 08:05:24
(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-05-2020 08:05:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-14-2020 08:21:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HEADA
CHETranscription
Error
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0860265
Page 199 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:YES
Ongoin
g?
NO
Stop
Date
:
Se
p/1
0/2
02
0
Oct-13-2020 19:59:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:NOTranscription
Error
Oct-13-2020 16:04:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HEADA
CHETranscription
Error
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0860266
Page 200 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:YES
Ongoin
g?
NO
Stop
Date
:
Se
p/1
0/2
02
0
Oct-13-2020 15:52:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:NOTranscription
Error
Oct-12-2020 11:36:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:YE
SNew Information
Oct-05-2020 08:05:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0860267
Page 201 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:NO
090177e196ae2f18\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0860268
Page 202 of 296
***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: 12311295 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Symptom:
Date Location User Value Reason
Oct-05-2020 08:05:24
(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-15-2020 03:29:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-14-2020 08:21:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/10/2020Transcription Error
Oct-13-2020
…[truncated]