125742 S1 M5 CRF c4591001 1231 12315677

Document text

Page 1 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891669
Page 2 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891670
Page 3 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315677]
2.Birth Date: /1982
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891671
Page 4 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891672
Page 5 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891673
Page 6 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891674
Page 7 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891675
Page 8 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [80.0]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [27.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891676
Page 9 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
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:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891677
Page 10 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [76056]
3.Randomization Group: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891678
Page 11 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BNTX0X]
5.bSample ID [BNTX0Y]
5.cSample ID [BNTX0Z]
5.dSample ID [BP270Y]
5.eSample ID [BP270Z]
5.fSample ID [BP2710]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891679
Page 12 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BP25TR]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891680
Page 13 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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/31/2020 18:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891681
Page 14 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891682
Page 15 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/19/2020
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891683
Page 16 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Sep/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891684
Page 17 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/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:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891685
Page 18 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BPWDY1]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891686
Page 19 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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/19/2020 10:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891687
Page 20 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891688
Page 21 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BNTWJY]
5.bSample ID [BPW5TF]
5.cSample ID [BNTWLL]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891689
Page 22 of 141
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/23/2021
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891690
Page 23 of 141
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: 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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/23/2021
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 [BS1R08]
5.bSample ID [BP1X5L]
5.cSample ID [BS1R63]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891691
Page 24 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891692
Page 25 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891693
Page 26 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891694
Page 27 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891695
Page 28 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891696
Page 29 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891697
Page 30 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891698
Page 31 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891699
Page 32 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891700
Page 33 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891701
Page 34 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891702
Page 35 of 141
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891703
Page 36 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891704
Page 37 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891705
Page 38 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891706
Page 39 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891707
Page 40 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891708
Page 41 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891709
Page 42 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891710
Page 43 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891711
Page 44 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891712
Page 45 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891713
Page 46 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891714
Page 47 of 141
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891715
Page 48 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891716
Page 49 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891717
Page 50 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891718
Page 51 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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 [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891719
Page 52 of 141
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891720
Page 53 of 141
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891721
Page 54 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Exposure during
pregnancy Dec/12/202
0 08:00 NO
End Date Time:
Feb/11/2021 23:00
 Repeating
Pages
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891722
Page 55 of 141
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: Dec/12/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/11/2021 23:00
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
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891723
Page 56 of 141
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891724
Page 57 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891725
Page 58 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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[ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891726
Page 59 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891727
Page 60 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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: //
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891728
Page 61 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891729
Page 62 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891730
Page 63 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891731
Page 64 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891732
Page 65 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891733
Page 66 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891734
Page 67 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891735
Page 68 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response -
Will the participant return for
consent/eligibility assessment
for the booster dose visit?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891736
Page 69 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/24/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891737
Page 70 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891738
Page 71 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891739
Page 72 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891740
Page 73 of 141
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891741
Page 74 of 141
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891742
Page 75 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 19:40:08 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891743
Page 76 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-31-2020 19:40:34 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891744
Page 77 of 141
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Jan-17-2021 18:37:56 (UTC-03:00) City
of Buenos AiresNot Applicable
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0891745
Page 78 of 141
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-23-2021 13:33:23 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-05-2021 15:23:48 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Feb-24-2021 14:47:41 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0891746
Page 79 of 141
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
 Approved Feb-16-2021 12:51:48 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Feb-13-2021 10:26:06 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-22-2021 08:44:59 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891747
Page 80 of 141
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
 N/A Jan-14-2021 17:02:14 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 22:26:13 (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.
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0891748
Page 81 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020
19:39:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020
19:39:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891749
Page 82 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020
19:39:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/31/2020Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891750
Page 83 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020
17:56:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12315677Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020
17:56:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1982Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020
19:39:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020
19:39:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGINInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891751
Page 84 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020
19:39:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891752
Page 85 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020
19:39:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891753
Page 86 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020
19:40:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020
19:40:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020
19:40:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891754
Page 87 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
80.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
170.0Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891755
Page 88 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires
5. Unit:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.7Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891756
Page 89 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
19:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891757
Page 90 of 141
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891758
Page 91 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogonad
otropin Beta
_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891759
Page 92 of 141
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
6.a Test:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020
19:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891760
Page 93 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020
19:42:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020
19:42:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
76056Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891761
Page 94 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
19:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
19:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
11:07:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-01-2020
04:49:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891762
Page 95 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Aug-31-2020
19:42:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-31-2020
19:42:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
11:07:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTX0XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
11:07:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTX0XInitial Entry
5.b
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891763
Page 96 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-01-2020
11:08:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTX0YInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020
11:08:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTX0YInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
11:08:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTX0ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020
11:08:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTX0ZInitial Entry
5.d
Date Location User Value Reason
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891764
Page 97 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-02-2020
11:55:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP270YInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-02-2020
11:55:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP270YInitial Entry
5.e
Date Location User Value Reason
Sep-02-2020
11:57:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP270ZInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020
11:57:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP270ZInitial Entry
5.f
Date Location User Value Reason
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891765
Page 98 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Sep-02-2020
11:57:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2710Initial Entry
5.f Sample ID
Date Location User Value Reason
Sep-02-2020
11:57:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP2710Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891766
Page 99 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
19:42:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
19:42:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
13:24:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-01-2020
04:49:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891767
Page 100 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Aug-31-2020
19:42:14
(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-31-2020
19:42:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
13:24:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP25TRInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
13:24:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP25TRInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891768
Page 101 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/31/2020 18:50Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891769
Page 102 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
19:42:27
(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-31-2020
19:42:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891770
Page 103 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-31-2020
19:42:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891771
Page 104 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020
19:42:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891772
Page 105 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020
11:15:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891773
Page 106 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020
11:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020
11:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ident
ifier::1
Temperature
:36.4
Temperature
Unit:C
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020
11:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891774
Page 107 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-19-2020
11:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020
11:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020
11:16:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891775
Page 108 of 141
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891776
Page 109 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogonad
otropin Beta
_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891777
Page 110 of 141
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
6.a Test:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Bet
a_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-19-2020
11:16:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891778
Page 111 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-19-2020
11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-19-2020
11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-19-2020
12:46:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-19-2020
11:16:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891779
Page 112 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Sep-19-2020
11:16:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/19/2020Initial Entry
5.a
Date Location User Value Reason
Sep-19-2020
12:46:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPWDY
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-19-2020
12:46:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWDY1Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891780
Page 113 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/19/2020 10:13Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891781
Page 114 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-19-2020
11:16:31
(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-19-2020
11:16:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECI
FIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891782
Page 115 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Sep-19-2020
11:16:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0891783
Page 116 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020
16:39:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891784
Page 117 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020
16:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020
16:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020
18:02:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-22-2020
16:39:16
(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
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891785
Page 118 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Oct-22-2020
16:39:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020
18:02:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BNTWJ
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020
18:02:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNTWJYInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020
18:27:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW5TFInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891786
Page 119 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sample ID
Date Location User Value Reason
Oct-22-2020
18:27:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPW5TFInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020
18:38:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BNTWL
LInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020
18:38:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNTWLLInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891787
Page 120 of 141
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-23-2021
13:33:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/23/2021Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891788
Page 121 of 141
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-23-2021
13:33:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-23-2021
13:33:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021
14:56:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-23-2021
13:33:33
(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
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891789
Page 122 of 141
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
appropriate.
Mar-23-2021
13:33:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/23/2021Initial Entry
5.a
Date Location User Value Reason
Mar-23-2021
14:56:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1R08Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-23-2021
14:56:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1R08Initial Entry
5.b
Date Location User Value Reason
Mar-23-2021
15:05:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP1X5LInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891790
Page 123 of 141
***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, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.b Sample ID
Date Location User Value Reason
Mar-23-2021
15:05:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1X5LInitial Entry
5.c
Date Location User Value Reason
Mar-23-2021
15:56:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1R63Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021
15:56:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1R63Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0891791
Page 124 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020
16:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020
16:39:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020
16:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891792
Page 125 of 141
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
14:48:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891793
Page 126 of 141
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021
14:48:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to r
eturn for Vaccination 3
Participant is:
eligible and NOT con
firmed to have receiv
ed only placebo at Va
ccination 1/2Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891794
Page 127 of 141
***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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Jan-14-2021
17:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891795
Page 128 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Jan-14-2021
17:02:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-14-2021
17:02:14
(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-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exposure during pregna
ncyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/12/2020 08:00Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891796
Page 129 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021
17:45:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-19-2021
17:09:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered Both in the HC
and in the FU of
February 12, the
end date was set
02/11/21 and
recovered status
Feb-18-2021
20:50:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical - End
date is 11Feb21;
however, PG
safety report
(#2021028567)
has no end date.
Please submit
end date /
Resolved status
to PG safety
report.
Feb-13-2021
10:26:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/11/2021 23:0
0New Information
Jan-14-2021
17:02:14ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (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-2021-5683-0891797
Page 130 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City
of Buenos Aires
6. Toxicity Grade:
Date Location User Value Reason
Jan-19-2021
16:55:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-17-2021
18:37:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Jan-17-2021
18:37:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New
Information
Jan-17-2021
18:37:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry: New
Information
Jan-15-2021
14:16:30
(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.
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891798
Page 131 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-14-2021
17:02:14
(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-19-2021
16:55:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Jan-17-2021
18:38:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription
Error
Jan-17-2021
18:38:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-17-2021
18:38:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOTranscription
Error
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0891799
Page 132 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-15-2021
14:16:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical As per
CRF CG
8.50.2.5, an
“Exposure
During
Pregnancy” is
not an SAE
[despite using
similar forms to
report
pregnancy];
only abnormal
outcomes of
pregnancy are
evaluated for
serious criteria.
Jan-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Exposure
during
pregnancy:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891800
Page 133 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolon
g hospitalization?
NO
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically im
portant serious even
t
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891801
Page 134 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Jan-14-2021
17:02:14
(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-14-2021
17:02:14
(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
Jan-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-14-2021
17:02:14
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891802
Page 135 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
of Buenos Aires
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Feb-24-2021
04:15:31
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
3: Clo
sedAcceptable discrepancy
Feb-21-2021
10:48:18
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
3: Rei
ssued:
Candi
dateFor Clinical review
Feb-19-2021
17:09:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
3: An
swere
dBoth in the HC and in the FU of
February 12, the end date was set
02/11/21 and recovered status
Feb-19-2021 ACV0PFEINFP6000  QuerySAE
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (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-2021-5683-0891803
Page 136 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
03:29:54
(UTC-03:00)
City of
Buenos
Aires3: Op
enedRECON:AER#2021028567,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-13-2021
10:26:25
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Feb-13-2021
10:26:25
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
REC
OVE
RED/
RESO
LVE
DNew Information
Feb-13-2021
10:26:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
enedFor 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-15-2021
09:45:39
(UTC-03:00)
City ofACV0PFEINFP6000  Query
1: Clo
sedClose per query response
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0891804
Page 137 of 141
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos
Aires
Jan-14-2021
20:19:49
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Santiago
CorradettiQuery
1: An
swere
dAs per CRF CR (section 8.50.2.5),
original value is correct. Exposure
during pregnancy outcome must be
'unknown' while is still ongoing.
thank you.
Jan-14-2021
17:02:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedFor 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-14-2021
17:02:14
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
UNK
NOW
NInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-14-2021
17:02:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891805
Page 138 of 141
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - 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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-24-2021
14:47:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-24-2021
14:47:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL VA
CCINATIONInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0891806
Page 139 of 141
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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1. Subject Status
Date Location User Value Reason
Oct-22-2020
16:39:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-31-2020
19:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Aug-31-2020
19:40:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-22-2020
16:39:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Aug-31-2020
19:42:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
Aug-31-2020
19:40:23
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/31/2020Initial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891807
Page 140 of 141
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
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: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0891808
Page 141 of 141
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor
Dr. Cosme Argerich
Subject No: 12315677 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
22:26:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e9b\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0891809