125742 S1 M5 CRF c4591001 1231 12314368

Document text

Page 1 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882741
Page 2 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882742
Page 3 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314368]
2.Birth Date: /1979
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882743
Page 4 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882744
Page 5 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882745
Page 6 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882746
Page 7 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882747
Page 8 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [51.0]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [20.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882748
Page 9 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/26/2020
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:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882749
Page 10 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [69213]
3.Randomization Group: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882750
Page 11 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTF49]
5.bSample ID [BPTF4B]
5.cSample ID [BPTF4C]
5.dSample ID [BNV2DR]
5.eSample ID [BNV2DS]
5.fSample ID [BNV2DT]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882751
Page 12 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPT9XR]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882752
Page 13 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/26/2020 19:35
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
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882753
Page 14 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882754
Page 15 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882755
Page 16 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882756
Page 17 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
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:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882757
Page 18 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2BHX]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882758
Page 19 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/16/2020 16:46
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
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882759
Page 20 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882760
Page 21 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBXDB]
5.bSample ID [BLBXCG]
5.cSample ID [BPW67F]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882761
Page 22 of 170
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882762
Page 23 of 170
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882763
Page 24 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882764
Page 25 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882765
Page 26 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882766
Page 27 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882767
Page 28 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882768
Page 29 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882769
Page 30 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882770
Page 31 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882771
Page 32 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882772
Page 33 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882773
Page 34 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882774
Page 35 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882775
Page 36 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882776
Page 37 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882777
Page 38 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882778
Page 39 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882779
Page 40 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882780
Page 41 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882781
Page 42 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882782
Page 43 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882783
Page 44 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882784
Page 45 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882785
Page 46 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882786
Page 47 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882787
Page 48 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/13/2021
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882788
Page 49 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/13/2021
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882789
Page 50 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/13/2021
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 [BS1VB8]
5.bSample ID [BRM8R7]
5.cSample ID [BS1RP4]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882790
Page 51 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/13/2021
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 [BRM8Z9]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882791
Page 52 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882792
Page 53 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/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 [BRMCMH]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882793
Page 54 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882794
Page 55 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/6/2021
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 [BR227X]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882795
Page 56 of 170
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/6/2021
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882796
Page 57 of 170
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882797
Page 58 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Supraclavicular a
denopathy (left) Aug/29/20
20 08:00 NO
End Date Time:
Oct/23/2020 08:0
0
 Repeating
Pages
 2.ADVERSE
EVENT 2  swollen tonsils  Sep/18/20
20 10:30 NO
End Date Time:
Oct/8/2020 10:00
 Repeating
Pages
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882798
Page 59 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[Supraclavicular adenopathy (left)]
4.Start Date Time: Aug/29/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/23/2020 08:00
6.Toxicity Grade: 1
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882799
Page 60 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882800
Page 61 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882801
Page 62 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[swollen tonsils]
4.Start Date Time: Sep/18/2020 10:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/8/2020 10:00
6.Toxicity Grade: 1
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882802
Page 63 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882803
Page 64 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882804
Page 65 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882805
Page 66 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882806
Page 67 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882807
Page 68 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: //
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882808
Page 69 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882809
Page 70 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882810
Page 71 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882811
Page 72 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882812
Page 73 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882813
Page 74 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882814
Page 75 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882815
Page 76 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882816
Page 77 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/6/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882817
Page 78 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882818
Page 79 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882819
Page 80 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/16/2020
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882820
Page 81 of 170
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882821
Page 82 of 170
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 01:58:17 (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.
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882822
Page 83 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 09:09:52 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882823
Page 84 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 09:10:21 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882824
Page 85 of 170
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-10-2021 01:58:17 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-08-2021 19:23:07 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-08-2021 15:55:57 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882825
Page 86 of 170
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
Agustin
Morato
Cabral N/A Feb-25-2021 13:35:18 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-17-2021 20:53:19 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882826
Page 87 of 170
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Martina
Davalli N/A Feb-13-2021 13:44:57 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-29-2020 13:43:19 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882827
Page 88 of 170
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Oct-27-2020 19:09:49 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-22-2020 15:55:23 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882828
Page 89 of 170
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882829
Page 90 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020
09:09:15
(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-27-2020
09:09:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882830
Page 91 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020
09:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Aug/26/2020Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882831
Page 92 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020
18:47:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314368Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020
18:47:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1979Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020
09:09:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882832
Page 93 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
09:09:31
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPANI
SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020
09:09:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882833
Page 94 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020
09:09:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882834
Page 95 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020
09:10:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020
09:10:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020
09:10:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882835
Page 96 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
51.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882836
Page 97 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
159.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.2Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.2Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882837
Page 98 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882838
Page 99 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020
09:10:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882839
Page 100 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882840
Page 101 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882841
Page 102 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020
09:11:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882842
Page 103 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020
09:11:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020
09:11:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
69213Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882843
Page 104 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
09:11:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
09:11:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
11:42:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-27-2020
12:50:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882844
Page 105 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
09:11:27
(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-27-2020
09:11:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
11:42:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTF4
9Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882845
Page 106 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-28-2020
11:42:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF49Initial Entry
5.b
Date Location User Value Reason
Aug-28-2020
11:42:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTF4
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
11:42:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF4BInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
11:43:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTF4
CInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882846
Page 107 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
11:43:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF4CInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020
19:27:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNV2D
RInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
19:27:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV2DRInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
19:27:46
(UTC-03:00) CityACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNV2D
SInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882847
Page 108 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
19:27:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV2DSInitial Entry
5.f
Date Location User Value Reason
Aug-28-2020
19:27:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNV2D
TInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-28-2020
19:27:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV2DTInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882848
Page 109 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020
09:11:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020
09:11:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
15:50:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-27-2020
12:50:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882849
Page 110 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Aug-27-2020
09:11:35
(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-27-2020
09:11:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
15:50:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPT9X
RInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882850
Page 111 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-28-2020
15:50:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPT9XRInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882851
Page 112 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882852
Page 113 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
09:12:00
(UTC-03:00) City
of Buenos AiresAug/26/2020 19:35
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882853
Page 114 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-27-2020
09:12:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882854
Page 115 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020
09:12:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882855
Page 116 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
12:22:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882856
Page 117 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
12:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020
12:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.0
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
12:22:30
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882857
Page 118 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-18-2020
12:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020
12:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
12:22:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882858
Page 119 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882859
Page 120 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882860
Page 121 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020
12:22:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882861
Page 122 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020
18:28:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020
18:28:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020
18:29:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-16-2020
18:28:54
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882862
Page 123 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Sep-16-2020
18:28:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collectio
n:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020
18:29:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BP2BH
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020
18:29:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP2BHXInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882863
Page 124 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882864
Page 125 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
12:22:53
(UTC-03:00) City
of Buenos AiresSep/16/2020 16:46
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882865
Page 126 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-18-2020
12:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882866
Page 127 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020
14:15:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882867
Page 128 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020
14:16:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020
14:16:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020
16:00:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-16-2020
14:16:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882868
Page 129 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Oct-16-2020
14:16:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020
16:00:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BLBXD
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020
16:00:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBXDBInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882869
Page 130 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-16-2020
16:48:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLBXC
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020
16:48:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLBXCGInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020
17:46:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BPW67
FInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020
17:46:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPW67FInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882870
Page 131 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020
14:16:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
14:16:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
14:16:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882871
Page 132 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-13-2021
13:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/13/2021Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882872
Page 133 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-13-2021
13:45:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/13/2021Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882873
Page 134 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-13-2021
13:45:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-13-2021
13:45:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-13-2021
15:26:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-13-2021
13:45:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882874
Page 135 of 170
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Feb-13-2021
13:45:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection
:
Feb/13/2021Initial Entry
5.a
Date Location User Value Reason
Feb-13-2021
15:26:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS1VB
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-13-2021
15:26:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1VB8Initial Entry
5.b
Date Location User Value Reason
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882875
Page 136 of 170
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-13-2021
16:24:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRM8R
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-13-2021
16:24:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRM8R7Initial Entry
5.c
Date Location User Value Reason
Feb-13-2021
16:52:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS1RP
4Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-13-2021
16:52:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS1RP4Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882876
Page 137 of 170
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-13-2021
14:53:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-13-2021
14:53:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021
09:47:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-15-2021
07:50:56
(UTC-03:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882877
Page 138 of 170
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Airesno barcodes
are entered.
Please review
and correct as
appropriate.
Feb-13-2021
14:53:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-13-2021
14:53:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Feb/13/2021Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021
09:47:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRM8
Z9Initial Entry
5.a Sample ID
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882878
Page 139 of 170
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Feb-17-2021
09:47:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRM8Z9Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882879
Page 140 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021
13:35:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Feb/23/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-25-2021
13:35:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
SSWAB_WEEK2Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882880
Page 141 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021
13:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021
13:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021
13:36:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-25-2021
13:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882881
Page 142 of 170
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Feb-25-2021
13:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
YES
Date of Collection
:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-25-2021
13:36:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample I
D:BRMCM
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-25-2021
13:36:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BRMCMHInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882882
Page 143 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
19:23:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/6/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-08-2021
19:23:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK4Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882883
Page 144 of 170
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021
19:24:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021
19:24:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021
19:24:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
19:24:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882884
Page 145 of 170
***Confidential***
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/06/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
are entered.
Please review
and correct as
appropriate.
Mar-08-2021
19:24:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Mar/6/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021
19:24:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR227
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021
19:24:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR227XInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882885
Page 146 of 170
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
12:33:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/6/2021Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882886
Page 147 of 170
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021
12:33:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinati
on 3
Participant is:
eligible and NOT c
onfirmed to have r
eceived only place
bo at Vaccination 1
/2Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882887
Page 148 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882888
Page 149 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882889
Page 150 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020
18:57:29
(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
Oct-21-2020
21:46:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-20-2020
15:30:56
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redTranscription
Error
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882890
Page 151 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Aires
Oct-20-2020
15:30:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Supraclavicular
adenopathy (left
)Transcription
Error
Oct-19-2020
22:00:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opene
dClinQuery:
Supraclavicular
adenopathy:
please Specify
whether
bilateral, left or
right
Sep-18-2020
18:57:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Supraclavicular
adenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/29/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882891
Page 152 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-27-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/23/2020 0
8:00New
Information
Oct-22-2020
10:18:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Oct-22-2020
09:04:35
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Maria Beretta Query 2: Answer
edOriginal value
is correct
Oct-20-2020
11:17:08
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened ClinQuery:
Participant was
seen for
V3PostVAX2
on 16 Oct
2020. Please
confirm if AE
is still
Ongoing. AE
start date 29
AUG 2020. If
AE Resolved,
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882892
Page 153 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
please update
AE record and
enter END
date.
Oct-01-2020
15:48:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-01-2020
12:19:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Query 1: Answer
edBased on
medical chart,
the EA is
ongoing.
Sep-29-2020
18:26:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened ClinQuery:
Please confirm
if AE is
ONGOING or
RESOLVED.
If
RESOLVED,
please update
AE record and
enter END
Date.
Sep-18-2020
18:57:29
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882893
Page 154 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020
18:57:29
(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
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-18-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882894
Page 155 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
18:57:29
(UTC-03:00) City
of Buenos AiresNO
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-02-2020
13:37:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Samuel
DychterQuery 1: Closed Response
satisfies query
Oct-01-2020
12:22:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Query 1: Answere
dIbuprofen 400
mg was
administered.
Etiology is still
unknown.The
subject has a
medical
appointment
with her doctor
on 5OCT2020.
Sep-21-2020
17:01:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Samuel
DychterQuery 1: Opened GPD Clin: A
concomitant
medication was
administered
for this AE.
Can you please
state what was
administered
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882895
Page 156 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
and is the
etiology
unknown, as
stated above?
Sep-18-2020
18:57:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, speci
fy:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020 ACV0PFEINFP6000  Data Entry: Transcription
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882896
Page 157 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
19:04:29
(UTC-03:00) City
of Buenos AiresYES Error
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020
11:20:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-28-2020
11:20:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERED/R
ESOLVEDNew
Information
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882897
Page 158 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-27-2020
19:09:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Supraclavicular
adenopathy
(left): Response
to "What was
the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but
AE End
Date/Time is
present.
Sep-18-2020
18:57:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RECOVER
ED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020
18:57:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882898
Page 159 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-06-2020
18:28:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
swollen tonsilsNew
Information
Sep-30-2020
18:27:22
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
left cervical adenop
athyInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882899
Page 160 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
of Buenos Aires
4. Start Date Time:
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/18/2020 10:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020
10:40:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/8/2020 10:
00New
Information
Oct-08-2020
11:28:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-06-2020
16:57:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Martina Davalli Query 1: Answere
dOriginal value
is correct
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882900
Page 161 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-06-2020
15:34:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened ClinQuery:
Please confirm
if AE is still
ONGOING or
RESOLVED.
If
RESOLVED,
please up AE
record and
enter END
Date.
Sep-30-2020
18:27:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-30-2020
18:27:22
(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
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882901
Page 162 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-07-2020
12:22:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-06-2020
16:55:32
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edTranscription
Error
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882902
Page 163 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires
Oct-06-2020
16:55:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Martina Davalli Data Entry:
NOT RELATED
If Not Related t
o study treatme
nt(s), this event
is due to:
OTHER
If Other, spe
cify:
UnknownTranscription
Error
Oct-01-2020
15:51:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened ClinQuery:
Subject has 2
AEs for
adenopathy. One
AE is
RELATED. One
AE is NOT
RELATED.
Please confirm
RELATEDNESS
for both AEs and
update if needed.
Also, please
confirm both
AEs are still
ONGOING. If
RESOLVED,
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882903
Page 164 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
please enter
END Date.
Sep-30-2020
18:27:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-02-2020
07:47:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-01-2020
12:18:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882904
Page 165 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-01-2020
12:18:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Mabel Berrueta Data Entry:
YESInitial Entry
Oct-01-2020
10:55:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened DM: The
response for
"Was a
Concomitant
Medication
given?" is
missing.
Kindly review
and update.
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-14-2020
10:40:33
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Clos
edClose Auto Query
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882905
Page 166 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires
Oct-14-2020
10:40:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERE
D/RESOLVE
DNew Information
Oct-14-2020
10:40:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Ope
nedFor AE swollen
tonsils: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Sep-30-2020
18:27:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERIN
G/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-30-2020
18:27:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882906
Page 167 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-08-2021
12:33:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/6/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-08-2021
12:33:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0882907
Page 168 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020
14:16:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020
09:11:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-27-2020
09:10:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-16-2020
14:16:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Aug-27-2020
09:11:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882908
Page 169 of 170
***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: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020
09:10:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882909
Page 170 of 170
***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, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314368 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020
15:55:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2e8c\Final\Final On: 01-Apr-2021 03:16 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882910