Document text
Page 1 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867035
Page 2 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/19/2020
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867036
Page 3 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12312378]
2.Birth Date: /1975
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867037
Page 4 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867038
Page 5 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867039
Page 6 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867040
Page 7 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867041
Page 8 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867042
Page 9 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867043
Page 10 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867044
Page 11 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [73.0]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [27.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867045
Page 12 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867046
Page 13 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [57467]
3.Randomization Group: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867047
Page 14 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BHY4YM]
5.bSample ID [BHY4YN]
5.cSample ID [BHY4YP]
5.dSample ID [BJ52B8]
5.eSample ID [BJ52B9]
5.fSample ID [BJ52BB]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867048
Page 15 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/19/2020
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 [BHY4V2]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867049
Page 16 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/19/2020 18:22
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
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867050
Page 17 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867051
Page 18 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867052
Page 19 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867053
Page 20 of 208
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867054
Page 21 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BP1YCF]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867055
Page 22 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 16:05
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
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867056
Page 23 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867057
Page 24 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNV61P]
5.bSample ID [BNV61R]
5.cSample ID [BP1VRJ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867058
Page 25 of 208
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867059
Page 26 of 208
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/2/2021
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 [BNTZ4F]
5.bSample ID [BR23NF]
5.cSample ID [BNTZ56]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867060
Page 27 of 208
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867061
Page 28 of 208
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867062
Page 29 of 208
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867063
Page 30 of 208
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867064
Page 31 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867065
Page 32 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/2/2020
2.Date of First Symptom Started: Aug/30/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/5/2020
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867066
Page 33 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headaches]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867067
Page 34 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Sep/2/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867068
Page 35 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867069
Page 36 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[sample collected by a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867070
Page 37 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP25T9]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867071
Page 38 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867072
Page 39 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867073
Page 40 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867074
Page 41 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867075
Page 42 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867076
Page 43 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867077
Page 44 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867078
Page 45 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867079
Page 46 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#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
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867080
Page 47 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867081
Page 48 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867082
Page 49 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867083
Page 50 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867084
Page 51 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867085
Page 52 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867086
Page 53 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867087
Page 54 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867088
Page 55 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867089
Page 56 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867090
Page 57 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867091
Page 58 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/05/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867092
Page 59 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPCMBT]
5.bSample ID [BPCMCN]
5.cSample ID [BP1VFX]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867093
Page 60 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867094
Page 61 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867095
Page 62 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867096
Page 63 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867097
Page 64 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867098
Page 65 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867099
Page 66 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867100
Page 67 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867101
Page 68 of 208
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867102
Page 69 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867103
Page 70 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867104
Page 71 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867105
Page 72 of 208
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867106
Page 73 of 208
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867107
Page 74 of 208
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867108
Page 75 of 208
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867109
Page 76 of 208
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867110
Page 77 of 208
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867111
Page 78 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1. DELETED ADVERSE E
VENT 1 Exposure during pr
egnancy Jan/18/2021
09:00 YES Repeating
Pages
2. ADVERSE E
VENT 2 Exposure during pr
egnancy Dec/24/2020
20:00 YES Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867112
Page 79 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Exposure during pregnancy ]
4.Start Date Time: Jan/18/2021 09:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[it is unknown ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867113
Page 80 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867114
Page 81 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Exposure during pregnancy]
4.Start Date Time: Dec/24/2020 20:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[it is unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867115
Page 82 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867116
Page 83 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867117
Page 84 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867118
Page 85 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867119
Page 86 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867120
Page 87 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867121
Page 88 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867122
Page 89 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867123
Page 90 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867124
Page 91 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867125
Page 92 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867126
Page 93 of 208
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867127
Page 94 of 208
***Confidential***
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867128
Page 95 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867129
Page 96 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867130
Page 97 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867131
Page 98 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/6/2020
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867132
Page 99 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867133
Page 100 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-22-2021 20:32:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867134
Page 101 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-20-2020 09:31:10 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0867135
Page 102 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Jan-26-2021 15:10:09 (UTC-03:00) City of
Buenos AiresAdolfo Gonzalez Not Applicable
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867136
Page 103 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-22-2021 20:32:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-19-2021 14:41:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Mar-17-2021 20:55:22 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-02-2021 14:25:30 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867137
Page 104 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Tatiana Estrada Approved Jan-29-2021 21:02:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, TatianaEstrada, 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.
Adolfo
Gonzalez N/A Jan-26-2021 15:09:53 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-25-2021 22:40:56 (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 Jan-23-2021 11:37:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-29-2020 13:24:01 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867138
Page 105 of 208
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-28-2020 14:01:57 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-22-2020 01:01:25 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0867139
Page 106 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 09:29:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-20-2020 09:29:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867140
Page 107 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 09:29:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867141
Page 108 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 16:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12312378Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 16:26:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 09:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 09:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 09:30:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867142
Page 109 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 09:30:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867143
Page 110 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65
and 85 years, inclusive, or
18 and 85 years, inclusive,
at randomization (depende
nt upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at randoInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867144
Page 111 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
mization (dependent upon study sta
ge)
1.a Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vac
cination plan, laboratory t
ests, lifestyle consideratio
ns, and other study proced
ures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867145
Page 112 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and ab
le to comply with all scheduled visi
ts, vaccination plan, laboratory test
s, lifestyle considerations, and othe
r study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867146
Page 113 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Healthy participants who
are determined by medical
history, physical examinat
ion, and clinical judgment
of the investigator to be el
igible for inclusion in the
study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867147
Page 114 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgment
of the investigator to be eligible for
inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867148
Page 115 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Capable of giving persona
l signed informed consent
, which includes complian
ce with the requirements a
nd restrictions listed in th
e ICD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867149
Page 116 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed i
nformed consent, which includes c
ompliance with the requirements a
nd restrictions listed in the ICD and
in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867150
Page 117 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (
within past year) or active
suicidal ideation/behavior/
lab abnormality that may i
ncrease the risk of study p
articipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condit
ion incl. recent (within past year) o
r active suicidal ideation/behavior/l
ab abnormality that may increase th
e risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867151
Page 118 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867152
Page 119 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatiti
s C virus (HCV), or hepatitis B vir
us (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867153
Page 120 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component of
the study intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867154
Page 121 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction
associated with a vaccine and/or se
vere allergic reaction (eg, anaphyla
xis) to any component of the study
intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867155
Page 122 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867156
Page 123 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Immunocompromised ind
ividuals with known or su
spected immunodeficienc
y, as determined by histor
y and/or laboratory/physi
cal examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX08A00
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867157
Page 124 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examina
tionInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867158
Page 125 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that woul
d, in the opinion of the in
vestigator, contraindicate
intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0867159
Page 126 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding th
at would, in the opinion of the inve
stigator, contraindicate intramuscul
ar injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breast
feedingInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867160
Page 127 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breast
feedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867161
Page 128 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion Des
cription:Previous vaccinati
on with any corona
virus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any coro
navirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-20-2020 09:30:50 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867162
Page 129 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresExclusio
n Numbe
r:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive ther
apy, such as cytotoxic a
gents or systemic cortic
osteroids
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX13A01
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867163
Page 130 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic ag
ents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglobu
lin, from 60 days before s
tudy intervention adminis
tration or planned receipt
throughout the studyInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867164
Page 131 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products o
r immunoglobulin, from 60 days be
fore study intervention administrati
on or planned receipt throughout th
e studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867165
Page 132 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descr
iption:Participation in other stu
dies involving study inte
rvention within 28 days
prior to study entry and/
or during study participa
tion
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867166
Page 133 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies invol
ving study intervention within 28 d
ays prior to study entry and/or duri
ng study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867167
Page 134 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
Descripti
on:Previous participation i
n other studies involvin
g study intervention co
ntaining lipid nanoparti
cles
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other stud
ies involving study intervention co
ntaining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867168
Page 135 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:22
Criter
ion De
scripti
on:Investigator site staff or Pf
izer employees directly in
volved in the conduct of t
he study, site staff otherwi
se supervised by the inves
tigator, and their respectiv
e family members
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867169
Page 136 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer emp
loyees directly involved in the con
duct of the study, site staff otherwi
se supervised by the investigator, a
nd their respective family member
sInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-20-2020 09:30:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867170
Page 137 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 09:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 09:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 09:31:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867171
Page 138 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
73.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
162.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City ofACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.8Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867172
Page 139 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
7.a
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 09:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867173
Page 140 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867174
Page 141 of 208
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-20-2020 09:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867175
Page 142 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 09:31:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 09:31:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
57467Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867176
Page 143 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 09:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 09:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 16:40:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 12:45:11
(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-20-2020 09:32:07
(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-20-2020 09:32:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867177
Page 144 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Aug-22-2020 16:40:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY4YMInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 16:40:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY4YMInitial Entry
5.b
Date Location User Value Reason
Aug-22-2020 16:40:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY4YNInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 16:40:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY4YNInitial Entry
5.c
Date Location User Value Reason
Aug-22-2020 16:40:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY4YPInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 16:40:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY4YPInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867178
Page 145 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d
Date Location User Value Reason
Aug-23-2020 11:12:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BJ52B8Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-23-2020 11:12:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BJ52B8Initial Entry
5.e
Date Location User Value Reason
Aug-23-2020 11:12:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BJ52B9Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-23-2020 11:12:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BJ52B9Initial Entry
5.f
Date Location User Value Reason
Aug-23-2020 11:13:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BJ52BBInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-23-2020 11:13:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BJ52BBInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867179
Page 146 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 09:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 09:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 12:19:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 12:45:11
(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-20-2020 09:32:17
(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-20-2020 09:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867180
Page 147 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Aug-22-2020 12:19:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHY4V2Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 12:19:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHY4V2Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867181
Page 148 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020 18:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 09:32:44
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867182
Page 149 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
7. Route:
Date Location User Value Reason
Aug-20-2020 09:32:44
(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-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-20-2020 09:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867183
Page 150 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020 09:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867184
Page 151 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 18:04:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867185
Page 152 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 18:05:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 18:05:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.9
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 18:05:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 18:05:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 18:05:12 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867186
Page 153 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresC
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 18:05:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867187
Page 154 of 208
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867188
Page 155 of 208
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020 18:05:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867189
Page 156 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 18:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 18:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 18:51:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 18:05:28
(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-08-2020 18:05:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 18:51:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
Sample ID: BP1YCFInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867190
Page 157 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 18:51:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Alan Colombo Data Entry:
BP1YCFInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867191
Page 158 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020 16:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867192
Page 159 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020 18:05:44
(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-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-08-2020 18:05:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867193
Page 160 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 02:47:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-15-2020 13:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The information
was uploaded
Thank you
Oct-14-2020 03:11:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Patient
completed the
treatment phase and
reached at Visit 3.
Kindly consider to
update EOT form
with matching V3
date or else clarify.
Thank you.
Oct-06-2020 16:00:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867194
Page 161 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 16:00:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 16:00:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 18:44:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 16:00:22
(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-06-2020 16:00:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 18:44:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNV61PInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867195
Page 162 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 18:44:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNV61PInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 19:34:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNV61RInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 19:34:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNV61RInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 12:03:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1VRJInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 12:03:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1VRJInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867196
Page 163 of 208
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 14:25:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/2/2021Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867197
Page 164 of 208
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021 14:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021 14:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 15:57:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 14:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-02-2021 14:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021 15:57:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTZ4FInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0867198
Page 165 of 208
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 15:57:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTZ4FInitial Entry
5.b
Date Location User Value Reason
Mar-03-2021 09:20:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR23NFInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021 09:20:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR23NFInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021 10:34:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTZ56Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-03-2021 10:34:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTZ56Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867199
Page 166 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-05-2020 10:12:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-05-2020 10:10:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-04-2020 12:40:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Sep-04-2020 12:40:50
(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.
Sep-04-2020 12:40:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Sep-04-2020 12:40:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867200
Page 167 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Sep-05-2020 10:10:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Sep-05-2020 10:10:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/30/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-29-2020 06:39:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 14:01:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-28-2020 14:01:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolve
d:
Oct/5/2020New Information
Oct-28-2020 11:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM Query:
Convalescent visit
occurred but Date of
Last Symptom
Resolved is missing.
Please confirm
symptoms are still
ongoing. If
symptoms have
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867201
Page 168 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
resolved update
response for
Symptom ongoing
as 'No' and add date
resolved.
Sep-05-2020 10:10:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867202
Page 169 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.b Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BRE
ATH
Sympto
m Prese
nt:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(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
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867203
Page 170 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867204
Page 171 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.f
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:YESInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867205
Page 172 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
4.g Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITINGInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867206
Page 173 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Symptom Present: NO
4.i Symptoms:
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Sep-05-2020 10:09:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Sep-05-2020 10:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other: headachesInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Sep-05-2020 10:09:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
headachesInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867207
Page 174 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867208
Page 175 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
ATILA BIOSYSTEMS IAMP COVInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0867209
Page 176 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires ID-19 DETECTION KIT
7. Test Result:
Date Location User Value Reason
Sep-05-2020 10:11:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867210
Page 177 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-05-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-05-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-05-2020 10:11:51
(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
Sep-05-2020 10:11:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
sample collected by a team physicia
nInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867211
Page 178 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-05-2020 10:12:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-05-2020 10:12:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 13:01:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-07-2020 05:15:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-05-2020 10:12:02
(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-05-2020 10:12:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0867212
Page 179 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Sep-07-2020 13:01:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP25T9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020 13:01:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP25T9Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867213
Page 180 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitione
r:EMERGENC
Y ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867214
Page 181 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Sep-05-2020 10:12:23
(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
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867215
Page 182 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE C
ONSULTATIO
N
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867216
Page 183 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867217
Page 184 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020 04:08:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-05-2020 10:12:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The information is
correct. The subject
has not been
hospitalized. The
subject did not need
visits or medical
attention. Thank
you.
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened There are no visits
or contacts reported
and subject has not
been hospitalized,
please confirm
whether the
participant sought
medical attention for
this respiratory
illness episode. If
not, please correct
data.
Sep-05-2020 10:12:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0867218
Page 185 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Sep/02/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Sep-05-2020 10:12:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Sep-05-2020 10:12:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Sep-05-2020 10:12:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867219
Page 186 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/05/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 10:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-06-2020 10:55:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867220
Page 187 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/05/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:55:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:55:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 11:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 10:55:12
(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.
Oct-06-2020 10:55:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 11:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPCMBTInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867221
Page 188 of 208
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/05/2020Form: 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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 11:13:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPCMBTInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 12:14:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
Sample ID: BPCMCNInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 12:14:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Agustin
Morato
CabralData Entry:
BPCMCNInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 08:35:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BP1VFXInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 08:35:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BP1VFXInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867222
Page 189 of 208
***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: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 13:18:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 13:18:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 13:18:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867223
Page 190 of 208
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-17-2021 17:43:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
Mar/2/2021Initial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0867224
Page 191 of 208
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-19-2021 14:41:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only place
bo at Vaccination 1/2Transcription Error
Mar-17-2021 17:43:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
Participant is NOT willing to r
eturn for Vaccination 3 OR oth
erwise not eligibleInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867225
Page 192 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-24-2021 12:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Santiago
CorradettiForm Deleted Duplicated
information
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867226
Page 193 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0867227
Page 194 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exposure during pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/18/2021 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867228
Page 195 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
it is unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867229
Page 196 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-24-2021 12:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867230
Page 197 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Jan-23-2021 11:37:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867231
Page 198 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exposure during pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 10:23:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/24/2020 20:00New Information
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/18/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0867232
Page 199 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312378 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
6. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021 14:05:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 15:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry:
Not ApplicableInitial Entry
Jan-26-2021 15:09:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-26-2021 15:09:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Adolfo Gonzalez Data Entry: Transcription Error
Jan-26-2021 13:27:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Clinical As per
CRF CG 8.50.2.5,
the toxicity grade
for “Exposure
During Pregnancy”
is reported as Not
Applicable
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-23-2021 11:40:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ef5\Final\Final On: 01-Apr-2021 03:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0867233
Page 200 of 208
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit
…[truncated]