Document text
Page 1 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874993
Page 2 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/23/2020
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874994
Page 3 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Demography
1.Subject ID [12313504]
2.Birth Date: /1984
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0874995
Page 4 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/23/2020
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874996
Page 5 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874997
Page 6 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874998
Page 7 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0874999
Page 8 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875000
Page 9 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875001
Page 10 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875002
Page 11 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Aug/23/2020
2.Weight: [93.0]
3.Unit: kg
4.Height: [177.0]
5.Unit: cm
6.Body Mass Index: [29.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875003
Page 12 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/23/2020
2.Randomization Number: [62966]
3.Randomization Group: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875004
Page 13 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/23/2020
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 [BNTN54]
5.bSample ID [BNTN55]
5.cSample ID [BP24D7]
5.dSample ID [BP24D8]
5.eSample ID [BP24D9]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875005
Page 14 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/23/2020
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 [BP26GD]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875006
Page 15 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/23/2020 16:01
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875007
Page 16 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875008
Page 17 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/13/2020
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875009
Page 18 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vital Signs
1.Date: Sep/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875010
Page 19 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/13/2020
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 [BP2BSN]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875011
Page 20 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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/13/2020 11:39
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875012
Page 21 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875013
Page 22 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BRXTX0]
5.bSample ID [BRXTXN]
5.cSample ID [BPT7MT]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875014
Page 23 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875015
Page 24 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/16/2020
2.Date of First Symptom Started: Dec/15/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/24/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875016
Page 25 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [sickness.]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875017
Page 26 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/16/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875018
Page 27 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/16/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875019
Page 28 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875020
Page 29 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWT0R]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875021
Page 30 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [Visiting physician]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875022
Page 31 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875023
Page 32 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875024
Page 33 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 Disease]
Date of Diagnosis:
Dec/16/2020
3.Toxicity Grade: 1
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875025
Page 34 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875026
Page 35 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875027
Page 36 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875028
Page 37 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875029
Page 38 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875030
Page 39 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875031
Page 40 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875032
Page 41 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875033
Page 42 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875034
Page 43 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875035
Page 44 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875036
Page 45 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875037
Page 46 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875038
Page 47 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875039
Page 48 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875040
Page 49 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875041
Page 50 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/28/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875042
Page 51 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BP1X9B]
5.bSample ID [BRYWM0]
5.cSample ID [BRYWJC]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875043
Page 52 of 220
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875044
Page 53 of 220
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Unplanned Assessments
1.Assessments
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875045
Page 54 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875046
Page 55 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875047
Page 56 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875048
Page 57 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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 [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875049
Page 58 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875050
Page 59 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875051
Page 60 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875052
Page 61 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875053
Page 62 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875054
Page 63 of 220
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875055
Page 64 of 220
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875056
Page 65 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875057
Page 66 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/25/2021
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875058
Page 67 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875059
Page 68 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875060
Page 69 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRZ1H6]
5.bSample ID [BR1ZT4]
5.cSample ID [BRZ1JJ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875061
Page 70 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BR20VF]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875062
Page 71 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 16:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875063
Page 72 of 220
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/17/2021
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875064
Page 73 of 220
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/17/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1LPY]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875065
Page 74 of 220
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/17/2021 10:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875066
Page 75 of 220
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875067
Page 76 of 220
***Confidential***
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875068
Page 77 of 220
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875069
Page 78 of 220
***Confidential***
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875070
Page 79 of 220
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875071
Page 80 of 220
***Confidential***
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875072
Page 81 of 220
***Confidential***
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875073
Page 82 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 cholelithiasis
Dec/24/2020 18:
00 NO
End Date Time:
Jan/5/2021 17:00
Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875074
Page 83 of 220
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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)[cholelithiasis]
4.Start Date Time: Dec/24/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/5/2021 17:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875075
Page 84 of 220
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?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[2020518594]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875076
Page 85 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875077
Page 86 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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[ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875078
Page 87 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875079
Page 88 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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: //
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875080
Page 89 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875081
Page 90 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875082
Page 91 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875083
Page 92 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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?
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875084
Page 93 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875085
Page 94 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875086
Page 95 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/18/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875087
Page 96 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875088
Page 97 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875089
Page 98 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/12/2020
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875090
Page 99 of 220
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875091
Page 100 of 220
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875092
Page 101 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormAug-23-2020 17:32:31 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875093
Page 102 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
ItemDate User Comment
FormFeb-26-2021 10:58:39 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875094
Page 103 of 220
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-17-2021 13:27:54 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-09-2021 14:39:53 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina Davalli N/A Feb-26-2021 10:57:55 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Yanina Rivera Approved Feb-19-2021 13:31:29 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875095
Page 104 of 220
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, YaninaRivera, 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-18-2021 12:23:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-09-2021 07:14:00 (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-04-2021 12:13:40 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Vanesa
Fainboim Approved Jan-20-2021 18:40:42 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875096
Page 105 of 220
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Affidavit:
By my dated signature below, I, VanesaFainboim, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-18-2020 12:09:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-30-2020 12:04:57 (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 Oct-29-2020 16:51:43 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-21-2020 21:27:35 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b)
(6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875097
Page 106 of 220
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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.
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875098
Page 107 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-23-2020 17:31:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-23-2020 17:31:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875099
Page 108 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-23-2020 17:31:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtained
Aug/23/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875100
Page 109 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-23-2020 15:12:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12313504Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-23-2020 15:12:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1984Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-23-2020 17:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-23-2020 17:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-23-2020 17:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
WHITEInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875101
Page 110 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-23-2020 17:31:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875102
Page 111 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participa
nts between the ages of 1
8 and 55 years, inclusive
, 65 and 85 years, inclusi
ve, or 18 and 85 years, i
nclusive, at randomizatio
n (dependent upon study
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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City ofACV0PFEINFP6000 Martina
DavalliData Entry:
Male or female participants betwInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875103
Page 112 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Buenos Aires 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)
1.a Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875104
Page 113 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875105
Page 114 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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 inc
lusion in the study
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875106
Page 115 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.c Inclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875107
Page 116 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875108
Page 117 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Inclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875109
Page 118 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Other medical or psychiatric con
dition incl. recent (within past ye
ar) or active suicidal ideation/beh
avior/lab abnormality that may in
crease the risk of study participat
ionInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875110
Page 119 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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 (HBV
)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875111
Page 120 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.b Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875112
Page 121 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875113
Page 122 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.c Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
History of severe adverse reactio
n associated with a vaccine and/o
r severe allergic reaction (eg, ana
phylaxis) to any component of th
e study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medica
tions intended to p
revent COVID-19Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875114
Page 123 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Receipt of medications intended
to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion Nu8Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875115
Page 124 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875116
Page 125 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.e Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875117
Page 126 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875118
Page 127 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.f Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeedingInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875119
Page 128 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Women who are pregnant or brea
stfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusion N
umber:12Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875120
Page 129 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccine
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Previous vaccination with any co
ronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875121
Page 130 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive th
erapy, such as cytotox
ic agents or systemic
corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX13A01Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875122
Page 131 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.i Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875123
Page 132 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0875124
Page 133 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.j Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Receipt of blood/plasma product
s or immunoglobulin, from 60 da
ys before study intervention adm
inistration or planned receipt thro
ughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX14A01Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875125
Page 134 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
2.k
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875126
Page 135 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.k Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875127
Page 136 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study intervent
ion containing lipid n
anoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX16A01Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875128
Page 137 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Exclu
sion N
umbe
r:22
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees directl
y involved in the conduc
t of the study, site staff o
therwise supervised by t
he investigator, and their
respective family memb
ers
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875129
Page 138 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.m Exclusion Number:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData 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-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-23-2020 17:32:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
EX21A01Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875130
Page 139 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-23-2020 17:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-23-2020 17:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-23-2020 17:32:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875131
Page 140 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
93.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
177.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875132
Page 141 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.7Initial Entry
7.a
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Record Identifier
::1
Temperature: 37.0
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-23-2020 17:33:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-23-2020 17:33:00 ACV0PFEINFP6000 Martina Data Entry: Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875133
Page 142 of 220
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of
Buenos AiresDavalli ORAL CAVITY
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875134
Page 143 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-23-2020 17:33:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-23-2020 17:33:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
62966Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875135
Page 144 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020 17:33:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020 17:33:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 18:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-24-2020 02:43:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-23-2020 17:33:21
(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-23-2020 17:33:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Aug/23/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875136
Page 145 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Aug-25-2020 18:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BNTN54Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 18:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BNTN54Initial Entry
5.b
Date Location User Value Reason
Aug-25-2020 18:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BNTN55Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020 18:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BNTN55Initial Entry
5.c
Date Location User Value Reason
Oct-29-2020 16:51:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24D7Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020 16:51:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP24D7Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875137
Page 146 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.d
Date Location User Value Reason
Oct-29-2020 16:51:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24D8Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020 16:51:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP24D8Initial Entry
5.e
Date Location User Value Reason
Oct-29-2020 16:51:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP24D9Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-29-2020 16:51:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP24D9Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875138
Page 147 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-23-2020 17:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-23-2020 17:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 15:52:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-24-2020 02:43:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-23-2020 17:33:31
(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-23-2020 17:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Aug/23/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875139
Page 148 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Aug-24-2020 15:52:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP26GDInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 15:52:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP26GDInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875140
Page 149 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Aug/23/2020 16:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875141
Page 150 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Aug-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-23-2020 17:33:52
(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-23-2020 17:33:52
(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-23-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875142
Page 151 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-23-2020 17:33:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875143
Page 152 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-13-2020 12:54:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/13/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875144
Page 153 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date:
Date Location User Value Reason
Sep-13-2020 12:54:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/13/2020Initial Entry
2.a
Date Location User Value Reason
Sep-13-2020 12:54:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-13-2020 12:54:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-13-2020 12:54:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-13-2020 12:54:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0875145
Page 154 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
2.a Temperature Location:
Date Location User Value Reason
Sep-13-2020 12:54:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875146
Page 155 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-13-2020 12:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-13-2020 12:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-13-2020 15:45:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-13-2020 12:54:48
(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.
Sep-13-2020 12:54:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/13/2020Initial Entry
5.a
Date Location User Value Reason
Sep-13-2020 15:45:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP2BSNInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875147
Page 156 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Sep-13-2020 15:45:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP2BSNInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875148
Page 157 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/13/2020 11:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875149
Page 158 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Sep-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-13-2020 12:55:11
(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-13-2020 12:55:11
(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-13-2020 12:55:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875150
Page 159 of 220
***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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 11:34:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875151
Page 160 of 220
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 11:34:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 11:34:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 12:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 11:34:40
(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.
Oct-13-2020 11:34:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 12:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXTX0Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875152
Page 161 of 220
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 12:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXTX0Initial Entry
5.b
Date Location User Value Reason
Oct-13-2020 13:06:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXTXNInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 13:06:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRXTXNInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020 13:38:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BPT7MTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020 13:38:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BPT7MTInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875153
Page 162 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 12:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 3: Closed Response satisfies
query
Jan-12-2021 10:35:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 3: Answered I am sorry, but even
though symptoms
overlapped, the
information
corresponding to
the SAE
'cholecystitis'
should not be
described in this
form. I will change
the uploaded data to
match the medical
history. Thank you.
Jan-11-2021 20:13:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 3: Opened Clin: Subject had
blood chemistry
performed as part of
the potential
COVID-19 illness,
please record the
results on the
appropriate CRF
page.
Dec-18-2020 12:11:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-18-2020 12:09:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875154
Page 163 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-18-2020 12:09:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-18-2020 12:09:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-18-2020 12:09:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0875155
Page 164 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-12-2021 10:35:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
NO
Date of Last Symptom Resolv
ed:
Dec/24/2020Changed
Information
Dec-23-2020 12:22:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolv
ed:
Dec/22/2020New Information
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875156
Page 165 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875157
Page 166 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.b Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875158
Page 167 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.c Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0875159
Page 168 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:YESInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875160
Page 169 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.f Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.g
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0875161
Page 170 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.h
Date Location User Value Reason
Dec-23-2020 12:19:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:YESNew Information
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-23-2020 12:19:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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), (b)
(6)
FDA-CBER-2021-5683-0875162
Page 171 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
4.i Symptoms:
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-18-2020 12:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-18-2020 12:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: HeadacheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-18-2020 12:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020 12:20:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: sickness.Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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), (b)
(6)
FDA-CBER-2021-5683-0875163
Page 172 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-23-2020 12:20:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
sickness.Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0875164
Page 173 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875165
Page 174 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875166
Page 175 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP CO
VID-19 DETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-18-2020 12:10:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875167
Page 176 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Dec-18-2020 12:11:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample collected by team physicia
nInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875168
Page 177 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 12:11:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 12:11:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-21-2020 12:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-21-2020 07:08:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 12:11:12
(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.
Dec-18-2020 12:11:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875169
Page 178 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Dec-21-2020 12:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BPWT0RInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-21-2020 12:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BPWT0RInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875170
Page 179 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1.a
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875171
Page 180 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-13-2021 12:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-12-2021 10:30:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 1: Answered I am sorry, but even
though symptoms
overlapped, the
information
corresponding to
the SAE
'cholecystitis'
should not be
described in this
form. I will change
the uploaded data to
match the medical
history. Thank you.
Jan-11-2021 20:20:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Please update
the response as YES
as per SAE
narrative(#
2020518594) "On
25Dec2020 at 20:00
hours the subject
arrived by himself
at ER where he was
admitted for further
treatment"
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875172
Page 181 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.c
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875173
Page 182 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875174
Page 183 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-12-2021 10:30:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Type of Practi
tioner:OTHER
Occurrence of
Visits or Cont
acts:YES
Number of Vi
sits or Conta
cts:
1Changed
Information
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875175
Page 184 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-12-2021 10:32:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-12-2021 10:30:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened “Other” is selected
, however other
specific item is
blank. Please
review and update
as appropriate.
Jan-12-2021 10:30:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
YES
Number of Visits or Contacts:
1Changed
Information
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Jan-12-2021 10:32:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
Visiting physicianInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b)
(4),
(b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875176
Page 185 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Jan-13-2021 12:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 2: Closed Response satisfies
query
Jan-13-2021 12:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-12-2021 10:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 2: Answered I am sorry, but even
though symptoms
overlapped, the
information
corresponding to the
SAE 'cholecystitis'
should not be
described in this
form. I will change
the uploaded data to
match the medical
history. Thank you.
Jan-12-2021 10:33:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiQuery 1: Answered I am sorry, but even
though symptoms
overlapped, the
information
corresponding to the
SAE 'cholecystitis'
should not be
described in this
form. I will change
the uploaded data to
match the medical
history. Thank you.
Jan-11-2021 20:18:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 2: Opened Clin: Please
complete the
hospitalization page
with all the
information
available: start/end
date, ICU?
Jan-11-2021 20:16:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Since the
subject was
hospitalized, please
update he response
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875177
Page 186 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
as YES
Dec-18-2020 12:11:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0875178
Page 187 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-18-2020 12:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-13-2021 12:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-12-2021 10:34:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered I am sorry, but even
though symptoms
overlapped, the
information
corresponding to the
SAE 'cholecystitis'
should not be
described in this form.
I will change the
uploaded data to
match the medical
history. Thank you.
Jan-12-2021 10:34:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiData Entry:
YES
Respiratory Illness Diagnos
is:
COVID-19 Disease
Date of Diagnosis:
Dec/16/2020I am sorry, but even
though symptoms
overlapped, the
information
corresponding to the
SAE 'cholecystitis'
should not be
described in this form.
I will change the
uploaded data to
match the medical
history. Thank you.
Jan-11-2021 20:15:43 ACV0PFEINFP6000 Salim Query 1: Opened Clin: Please consider
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875179
Page 188 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
(UTC-03:00) City of
Buenos AiresBouguermouh in response to "Was a
diagnosis obtained for
Potential COVID-19
Illness" entering
"CHOLELITHIASIS"
instead of "stomach
flu"
Dec-23-2020 13:35:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnos
is:
stomach flu.
Date of Diagnosis:
Dec/22/2020New Information
Dec-18-2020 12:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 12:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b)
(4),
(b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875180
Page 189 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/28/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 12:13:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/28/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-04-2021 12:13:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875181
Page 190 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 12:14:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 12:14:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021 14:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-04-2021 17:52:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-04-2021 12:14:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-04-2021 12:14:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875182
Page 191 of 220
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a
Date Location User Value Reason
Feb-08-2021 14:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1X9BInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021 14:21:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1X9BInitial Entry
5.b
Date Location User Value Reason
Feb-08-2021 14:37:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRYWM0Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-08-2021 14:37:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRYWM0Initial Entry
5.c
Date Location User Value Reason
Feb-08-2021 14:39:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRYWJCInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-08-2021 14:39:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRYWJCInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0875183
Page 192 of 220
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-13-2020 11:34:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 11:34:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 11:34:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875184
Page 193 of 220
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021 12:23:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Feb/18/2021Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875185
Page 194 of 220
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-18-2021 12:23:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per other protocol allo
wance(s) and confirmed to hav
e received only placebo at Vac
cination 1/2Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875186
Page 195 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 10:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/25/2021Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875187
Page 196 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-26-2021 10:58:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtained
Feb/25/2021Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875188
Page 197 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-26-2021 10:58:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-26-2021 10:58:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-26-2021 10:58:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875189
Page 198 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 10:59:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 10:59:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 11:08:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 10:59:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 10:59:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 11:08:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ1H6Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875190
Page 199 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 11:08:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ1H6Initial Entry
5.b
Date Location User Value Reason
Feb-26-2021 12:41:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR1ZT4Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021 12:41:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR1ZT4Initial Entry
5.c
Date Location User Value Reason
Feb-26-2021 12:48:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRZ1JJInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021 12:48:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRZ1JJInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (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-2021-5683-0875191
Page 200 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 11:54:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 10:59:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 11:54:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BR20VFInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875192
Page 201 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 11:54:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BR20VFInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875193
Page 202 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
Feb/25/2021 16:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875194
Page 203 of 220
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-26-2021 10:59:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0875195
Page 204 of 220
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313504 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:20
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-17-2021 13:27:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/17/2021Initial Entry
090177e196ae2ef0\Final\Final On: 01-Apr-2021 03:28 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0875196
Page 205 of 220
***Confidential***
Header Text: C4591
…[truncated]