125742 S1 M5 CRF c4591001 1231 12315429

Document text

Page 1 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889301
Page 2 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/30/2020
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889302
Page 3 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Demography
1.Subject ID [12315429]
2.Birth Date: /1983
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889303
Page 4 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/30/2020
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889304
Page 5 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889305
Page 6 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889306
Page 7 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889307
Page 8 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vital Signs
1.Date: Aug/30/2020
2.Weight: [54.0]
3.Unit: kg
4.Height: [156.0]
5.Unit: cm
6.Body Mass Index: [22.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889308
Page 9 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/30/2020
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:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889309
Page 10 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/30/2020
2.Randomization Number: [74367]
3.Randomization Group: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889310
Page 11 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/30/2020
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 [BNV37P]
5.bSample ID [BNV37R]
5.cSample ID [BP25GS]
5.dSample ID [BP25GT]
5.eSample ID [BP25GV]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889311
Page 12 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/30/2020
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 [BPTFYK]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889312
Page 13 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/30/2020 10:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889313
Page 14 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889314
Page 15 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT Comments
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889315
Page 16 of 164
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889316
Page 17 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889317
Page 18 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889318
Page 19 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Applicable Comments
2.Treatment Name Not Applicable
[ ]Comments
3.Formulation: Not Applicable Comments
4.Dose Date Time: Not Applicable
//Comments
5.Anatomical Location: Not Applicable Comments
6.Body Side: Not Applicable Comments
7.Route: Not Applicable Comments
8.Actual Dose: Not Applicable
[ ]Comments
9.Unit: Not Applicable Comments
10.Timeframe Subject Was Observed Not Applicable Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Applicable Comments
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889319
Page 20 of 164
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889320
Page 21 of 164
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889321
Page 22 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889322
Page 23 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889323
Page 24 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889324
Page 25 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889325
Page 26 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889326
Page 27 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889327
Page 28 of 164
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889328
Page 29 of 164
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889329
Page 30 of 164
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889330
Page 31 of 164
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889331
Page 32 of 164
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889332
Page 33 of 164
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889333
Page 34 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889334
Page 35 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889335
Page 36 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889336
Page 37 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Unplanned Assessments
1.Assessments
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889337
Page 38 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889338
Page 39 of 164
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889339
Page 40 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889340
Page 41 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889341
Page 42 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889342
Page 43 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889343
Page 44 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889344
Page 45 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889345
Page 46 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889346
Page 47 of 164
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889347
Page 48 of 164
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889348
Page 49 of 164
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889349
Page 50 of 164
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889350
Page 51 of 164
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889351
Page 52 of 164
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889352
Page 53 of 164
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889353
Page 54 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ongo
ingForm Instance
 1.ADVERSE EVEN
T 1  pain at injection si
te Aug/30/2020 10:3
4 NO
End Date Time:
Sep/16/2020 09:00
 Repeating
Pages
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889354
Page 55 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pain at injection site]
4.Start Date Time: Aug/30/2020 10:34
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/16/2020 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
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
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889355
Page 56 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889356
Page 57 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889357
Page 58 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889358
Page 59 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889359
Page 60 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889360
Page 61 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889361
Page 62 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889362
Page 63 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889363
Page 64 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889364
Page 65 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889365
Page 66 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889366
Page 67 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889367
Page 68 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Booster Dose Trigger Form
1.Select appropriate response - Will the
participant return for
consent/eligibility assessment for the
booster dose visit?
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889368
Page 69 of 164
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889369
Page 70 of 164
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Oct/5/2020
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889370
Page 71 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889371
Page 72 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/5/2020
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889372
Page 73 of 164
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889373
Page 74 of 164
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Nov-10-2020 18:06:14 (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.
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889374
Page 75 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-30-2020 12:32:36 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889375
Page 76 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormAug-30-2020 12:33:01 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889376
Page 77 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormOct-28-2020 11:24:56 (UTC-03:00) City of Buenos
Aires
FormOct-26-2020 10:38:07 (UTC-03:00) City of Buenos
AiresNot Applicable
FormOct-23-2020 17:48:37 (UTC-03:00) City of Buenos
Aires
FormOct-23-2020 13:06:12 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889377
Page 78 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-28-2020 11:24:56 (UTC-03:00) City of Buenos
Aires
1Oct-26-2020 10:38:07 (UTC-03:00) City of Buenos
AiresNot Applicable
1Oct-23-2020 17:48:37 (UTC-03:00) City of Buenos
Aires
1Oct-23-2020 13:06:12 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889378
Page 79 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Oct-28-2020 11:24:56 (UTC-03:00) City of Buenos
Aires
2Oct-26-2020 10:38:07 (UTC-03:00) City of Buenos
AiresNot Applicable
2Oct-23-2020 17:48:37 (UTC-03:00) City of Buenos
Aires
2Oct-23-2020 13:06:12 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889379
Page 80 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormOct-26-2020 10:38:21 (UTC-03:00) City of Buenos
AiresNot Applicable
FormOct-23-2020 17:50:58 (UTC-03:00) City of Buenos
Aires
FormOct-23-2020 13:06:26 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889380
Page 81 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-26-2020 10:38:21 (UTC-03:00) City of Buenos
AiresNot Applicable
1Oct-23-2020 17:50:58 (UTC-03:00) City of Buenos
Aires
1Oct-23-2020 13:06:26 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889381
Page 82 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2.aOct-26-2020 10:38:21 (UTC-03:00) City of Buenos
AiresNot Applicable
2.aOct-23-2020 17:50:58 (UTC-03:00) City of Buenos
Aires
2.aOct-23-2020 13:06:26 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889382
Page 83 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2.aOct-26-2020 10:38:21 (UTC-03:00) City of Buenos
AiresNot Applicable
2.aOct-23-2020 17:50:58 (UTC-03:00) City of Buenos
Aires
2.aOct-23-2020 13:06:26 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889383
Page 84 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2.aOct-26-2020 10:38:21 (UTC-03:00) City of Buenos
AiresNot Applicable
2.aOct-23-2020 17:50:58 (UTC-03:00) City of Buenos
Aires
2.aOct-23-2020 13:06:26 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889384
Page 85 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormOct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
FormOct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
FormOct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889385
Page 86 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
1Oct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
1Oct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889386
Page 87 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Oct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
2Oct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
2Oct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889387
Page 88 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Oct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
3Oct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
3Oct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889388
Page 89 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Oct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
4Oct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
4Oct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889389
Page 90 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Oct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
5Oct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
5Oct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889390
Page 91 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aOct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
6.aOct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
6.aOct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889391
Page 92 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aOct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
6.aOct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
6.aOct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889392
Page 93 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6.aOct-26-2020 10:38:45 (UTC-03:00) City of Buenos
AiresNot Applicable
6.aOct-23-2020 17:51:19 (UTC-03:00) City of Buenos
Aires
6.aOct-23-2020 13:06:41 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889393
Page 94 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormOct-26-2020 10:40:21 (UTC-03:00) City of Buenos
AiresNot Applicable
FormOct-23-2020 17:51:39 (UTC-03:00) City of Buenos
Aires
FormOct-23-2020 13:06:53 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889394
Page 95 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-26-2020 10:40:21 (UTC-03:00) City of Buenos
AiresNot Applicable
1Oct-23-2020 17:51:39 (UTC-03:00) City of Buenos
Aires
1Oct-23-2020 13:06:53 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889395
Page 96 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Oct-26-2020 10:40:21 (UTC-03:00) City of Buenos
AiresNot Applicable
2Oct-23-2020 17:51:39 (UTC-03:00) City of Buenos
Aires
2Oct-23-2020 13:06:53 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889396
Page 97 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Oct-26-2020 10:40:21 (UTC-03:00) City of Buenos
AiresNot Applicable
3Oct-23-2020 17:51:39 (UTC-03:00) City of Buenos
Aires
3Oct-23-2020 13:06:53 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889397
Page 98 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Oct-26-2020 10:40:21 (UTC-03:00) City of Buenos
AiresNot Applicable
4Oct-23-2020 17:51:39 (UTC-03:00) City of Buenos
Aires
4Oct-23-2020 13:06:53 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889398
Page 99 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
FormOct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
FormOct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
FormOct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889399
Page 100 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
1Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
1Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
1Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889400
Page 101 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
2Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
2Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
2Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889401
Page 102 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
3Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
3Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
3Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889402
Page 103 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
4Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
4Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
4Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889403
Page 104 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
5Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
5Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
5Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889404
Page 105 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
6Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
6Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
6Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889405
Page 106 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
7Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
7Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
7Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889406
Page 107 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
8Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
8Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
8Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889407
Page 108 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
9Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
9Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
9Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889408
Page 109 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
10Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
10Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
10Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889409
Page 110 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
ItemDate User Comment
11Oct-26-2020 10:40:34 (UTC-03:00) City of Buenos
AiresNot Applicable
11Oct-23-2020 17:50:31 (UTC-03:00) City of Buenos
Aires
11Oct-23-2020 13:07:06 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889410
Page 111 of 164
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Nov-10-2020 18:06:14 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-10-2020 08:45:33 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-29-2020 18:48:40 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-28-2020 11:24:56 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 19:50:54 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889411
Page 112 of 164
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
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-26-2020 10:38:07 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-23-2020 17:57:08 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-23-2020 13:06:12 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-21-2020 17:53:21 (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.
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (6)
(b) 
(6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889412
Page 113 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-30-2020 12:31:47
(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-30-2020 12:31:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889413
Page 114 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-30-2020 12:32:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/30/2020Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889414
Page 115 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-30-2020 10:00:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12315429Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-30-2020 10:00:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1983Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-30-2020 12:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-30-2020 12:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-30-2020 12:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889415
Page 116 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-30-2020 12:32:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889416
Page 117 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-30-2020 12:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-30-2020 12:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-30-2020 12:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889417
Page 118 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
54.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
156.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.2Initial Entry
7.a
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889418
Page 119 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-30-2020 12:33:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889419
Page 120 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889420
Page 121 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-30-2020 12:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889421
Page 122 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-30-2020 12:33:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-30-2020 12:33:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
74367Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889422
Page 123 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020 12:34:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020 12:34:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 16:55:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-30-2020 12:34:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-30-2020 12:34:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/30/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 16:55:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BNV37PInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889423
Page 124 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020 16:55:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV37PInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 16:55:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BNV37RInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 16:55:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNV37RInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 17:32:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP25GSInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 17:32:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP25GSInitial Entry
5.d
Date Location User Value Reason
Aug-31-2020 17:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP25GTInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889424
Page 125 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 17:32:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP25GTInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020 17:33:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP25GVInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 17:33:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP25GVInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889425
Page 126 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020 12:34:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020 12:34:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 10:17:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-30-2020 12:34:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-30-2020 12:34:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/30/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 10:17:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTFYKInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889426
Page 127 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Aug-31-2020 10:17:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTFYKInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889427
Page 128 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020 10:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889428
Page 129 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-30-2020 12:34:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889429
Page 130 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-30-2020 12:34:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889430
Page 131 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020
16:13:07
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 3
: Delete
dNot Applicable is entered
for other assessments.
Oct-28-2020
14:32:17
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 4
: ClosedResponse satisfies query
Oct-28-2020
14:31:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2
: ClosedResponse satisfies query
Oct-28-2020
11:58:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 4
: Answe
redFORM WAS STARTED IN
ERROR
Oct-28-2020
11:57:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4
: Opene
dDate of Visit is after the
Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form. Please
review and update as
appropriate.
Oct-28-2020
11:57:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3
: Candi
dateErroneous Visit is marked,
but date of visit is entered.
Please check whether other
assessments are performed
at this visit.
Oct-28-2020
11:57:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2
: Answe
redInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889431
Page 132 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-28-2020
11:57:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Oct/22/
2020Initial Entry
Oct-28-2020
11:24:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:Initial Entry
Oct-28-2020
08:08:22
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2
: Reissu
ed:Ope
nedDM1: Please review if this
visit was initiated in error. If
yes, check the Erroneous
visit checkbox.
Oct-27-2020
12:03:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2
: Answe
redErroneous visit. visit was
not done
Oct-27-2020
07:24:10
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2
: Opene
dDMW5185076;Date of
Visit is not expected to be
Unknown or Not
Applicable. Please review
and update appropriately or
clarify
Oct-26-2020
10:38:07
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Not Ap
plicableInitial Entry
Oct-23-2020
17:48:37
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:Initial Entry
Oct-23-2020
13:06:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
Not Ap
plicableInitial Entry
Oct-04-2020
10:08:00
(UTC-03:00)ACV0PFEINFP6000  Query 1
: ClosedResponse satisfies query
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889432
Page 133 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos Aires
Oct-03-2020
16:14:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Answe
redSubject did not visit 2.
Thank You
Sep-26-2020
13:37:20
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Opene
dDM: Kindly review and
complete ‘Date of Visit,
Nasal Swab, Pregnancy
Test, Vaccination, Vital
Signs' forms at this visit.
Thank you.
2. Erroneous Visit
Date Location User Value Reason
Oct-28-2020 11:28:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
Oct-28-2020 11:24:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-26-2020 10:38:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:48:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889433
Page 134 of 164
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020
08:07:14
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies
query
Oct-27-2020
12:07:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: An
sweredErroneous visit
Oct-27-2020
07:29:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Op
enedDMW5185160;Vitals
Date is not expected
to be Unknown or
Not Applicable.
Please review and
update appropriately
or clarify
Oct-26-2020
10:38:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:
Not Applica
bleInitial Entry
Oct-23-2020
17:50:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:Initial Entry
Oct-23-2020
13:06:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:
Not Applica
bleInitial Entry
2.a
Date Location User Value Reason
Oct-26-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: Not Applica
bleInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889434
Page 135 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Temperature: Not Applica
ble
Temperature Unit: Not Applica
ble
Temperature Locati
on::Not Applica
ble
Oct-23-2020 17:50:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: Not Applica
ble
Temperature:
Temperature Unit:
Temperature Locati
on::Initial Entry
Oct-23-2020 13:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: Not Applica
ble
Temperature: Not Applica
ble
Temperature Unit: Not Applica
ble
Temperature Locati
on::Not Applica
bleInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-23-2020 13:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a Temperature:
Date Location User Value Reason
Oct-26-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889435
Page 136 of 164
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
2.a Unit:
Date Location User Value Reason
Oct-26-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-26-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889436
Page 137 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889437
Page 138 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:
Test:: Not Applic
able
Result::Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889438
Page 139 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Not Done::
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889439
Page 140 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
6.a Not Done:
Date Location User Value Reason
Oct-26-2020 10:38:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889440
Page 141 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 10:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 10:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 10:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889441
Page 142 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-26-2020 10:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:06:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889442
Page 143 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-28-2020
08:07:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies
query
Oct-27-2020
12:07:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: An
sweredErroneous visit
Oct-27-2020
07:07:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Op
enedDMW5185068;Temp
Delay is not expected
to be Unknown or
Not Applicable.
Please review and
update appropriately
or clarify
Oct-26-2020
10:40:34
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:
Not Applica
bleInitial Entry
Oct-23-2020
17:50:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:Initial Entry
Oct-23-2020
13:07:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry
:
Not Applica
bleInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889443
Page 144 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Dose Date Time:
Date Location User ValueReason
Oct-28-2020
08:07:43
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Oct-27-2020
12:08:22
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: Ans
weredErroneous visit
Oct-27-2020
07:11:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW5185052;Dose Date is
not expected to be Unknown
or Not Applicable. Please
review and update
appropriately or clarify
Oct-26-2020
10:40:34
(UTC-03:00)ACV0PFEINFP6000  Data
Entry
:Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889444
Page 145 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
City of
Buenos
AiresNot A
pplica
ble
Oct-25-2020
10:45:11
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Oct-23-2020
17:54:52
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Ans
weredsubject called to report
wanting to withdraw consent
on October 5. because of that
there will be no more visits.
Thank you
Oct-23-2020
17:50:31
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:Initial Entry
Oct-23-2020
16:29:26
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5169206;Randomization
number is recorded and the
final disposition date is
present on the Disposition -
Follow-up eCRF, but there is
no dosing date present on the
Treatment eCRF. Please
review and update as
appropriate.
Oct-23-2020
13:07:06
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0889445
Page 146 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos Aires
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Route:
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889446
Page 147 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00) City of
Buenos AiresNot Applicable
9. Unit:
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-26-2020 10:40:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Oct-23-2020 17:50:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Initial Entry
Oct-23-2020 13:07:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0889447
Page 148 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-06-2020 17:13:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020 17:13:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-10-2020 13:57:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 2: Closed Response satisfies
query
Nov-10-2020 12:51:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-10-2020 12:50:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Nov-10-2020 12:50:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Nov-10-2020 12:50:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Nov-10-2020 10:53:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Opened CLINQUERY: Since it
is confirmed that the
AE of injection site
pain led to the
decision to withdraw
from treatment and the
study, please update
this field to match
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889448
Page 149 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(status ADVERSE
EVENT to be
selected)
Nov-09-2020 11:51:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered Pain at the site of
injection is stated
Nov-09-2020 10:46:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINQUERY: Page
indicates subject chose
to withdraw from
Rx/study due to pain
from injection. If so,
please consider
updating EOT status
to be ADVERSE
EVENT in order to
link the AE to this
withdrawal. AE to be
updated too
Nov-09-2020 08:55:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 2: Candidate CLINQUERY: Page
indicates subject chose
to withdraw from
Rx/study due to pain
from injection. If so,
please consider
updating EOT status
to be ADVERSE
EVENT in order to
link the AE to this
withdrawal. AE to be
updated too
Oct-14-2020 14:12:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed will issue query from
DISPOSITION-
FOLLOW UP CRF to
help site understand
what needs to be
completed.
Oct-14-2020 09:44:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered withdrawal of consent
Oct-12-2020 15:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened CLINQUERY: The
DISPOSITION-
FOLLOW UP CRF
has not yet been
completed. Please
complete that form.
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889449
Page 150 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Thank you.
Oct-11-2020 13:49:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The form is already
loaded. Thank you
Oct-07-2020 13:12:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY:
According to the
DISPOSITION-
TREATMENT CRF
the subject
discontinued treatment
due to
WITHDRAWAL BY
SUBJECT. Please
complete the
DISPOSITION-
FOLLOW UP CRF.
Thank you.
Oct-06-2020 17:13:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-10-2020
12:51:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry: Changed
Information
Oct-15-2020
09:35:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Close
dclosed per site
response
Oct-14-2020
10:00:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answ
eredAdverse event
(pain at the site
of application of
the research
product) is
added to the
redcap and the
report
Oct-07-2020
20:02:03ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Open
edPlease review
Specify Status
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889450
Page 151 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(UTC-03:00)
City of Buenos
Airesfield, the
following text
was indicated in
the comment
field [pain]. Any
symptoms, AEs
or other key data
should be
collected on the
appropriate
page. Please
review and
update as
necessary.
Oct-06-2020
17:13:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
for the pain yo
u felt after rece
iving the first
dose of the res
earch product.Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889451
Page 152 of 164
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-10-2020 13:58:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 3: Closed Response satisfies
query
Nov-10-2020 12:52:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Nov-10-2020 12:52:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Nov-10-2020 12:52:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed Information
Nov-10-2020 12:52:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ADVERSE EVENTChanged Information
Nov-10-2020 10:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 3: Reissued:Opened CLINQUERY: Since it
is confirmed that the
AE of injection site
pain led to the
decision to withdraw
from treatment and the
study, please update
this field to match
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889452
Page 153 of 164
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
(status ADVERSE
EVENT to be
selected)
Nov-09-2020 12:17:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Query 3: Answered subject chose to
withdraw from study
due to pain from
injection, this is
described in
reactogenicity because
it started the day after
vaccination. We don´t
have more data to
update an AE since
the subject withdraw
consent
Nov-09-2020 10:48:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened CLINQUERY: Page
indicates subject chose
to withdraw from
Rx/study due to pain
from injection. If so,
please consider
updating EOT status
to be ADVERSE
EVENT in order to
link the AE to this
withdrawal. AE to be
updated too
Nov-09-2020 08:55:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 3: Candidate CLINQUERY: Page
indicates subject chose
to withdraw from
Rx/study due to pain
from injection. If so,
please consider
updating EOT status
to be ADVERSE
EVENT in order to
link the AE to this
withdrawal. AE to be
updated too
Oct-15-2020 17:38:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-15-2020 16:13:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889453
Page 154 of 164
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
WITHDRAWAL BY SUBJECTInitial Entry
Oct-14-2020 14:13:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY:
According to the
DISPOSITION-
TREATMENT CRF
the subject
discontinued treatment
due to
WITHDRAWAL BY
SUBJECT. Please
complete the
DISPOSITION-
FOLLOW UP CRF.
Thank you.
4. Specify Status:
Date Location User Value Reason
Nov-10-2020 12:52:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Changed Information
Oct-15-2020 16:13:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
For the pain felt after receiving the f
irst dose of the research product.Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889454
Page 155 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
Date Location User Value Reason
Oct-14-2020 09:59:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889455
Page 156 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Category:
Date Location User Value Reason
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-14-2020 09:59:24
(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-15-2020
21:31:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Oct-15-2020
17:39:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-15-2020
15:43:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription
Error
Oct-15-2020
15:43:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-15-2020
15:43:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
pain at injection sit
eTranscription
Error
Oct-15-2020
12:39:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINQUERY:
Please report as
pain at injection
site rather than
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889456
Page 157 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
pain at the
"application" site.
Thank you.
Oct-14-2020
21:25:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Special
Characters:
Verbatim Term
contains
embedded
non-compliant
characters.
Oct-14-2020
09:59:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
pain at the site of a
pplication of the re
search productInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/30/2020 10:34Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/16/2020 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial 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).
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889457
Page 158 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Date Location User Value Reason
Oct-14-2020 09:59:24
(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
Oct-14-2020 09:59:24
(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-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-10-2020 13:59:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-10-2020 08:45:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-10-2020 08:45:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DRUG WITHDRAWNTranscription Error
Nov-09-2020 21:01:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: EOT
tab reports subject
discontinued due to
pain at injection site. if
correct, please review
this entry of 'Not
Applicable' in regard
to action with study
treatment. If led to Rx
discount., please
update to DRUG
WITHDRAWN
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889458
Page 159 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Nov-09-2020 11:58:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY: EOT
tab reports subject
discontinued due to
pain at injection site. if
correct, please review
this entry of 'Not
Applicable' in regard
to action with study
treatment. If led to Rx
discount., please
update to DRUG
WITHDRAWN
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-14-2020 09:59:24
(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 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-10-2020 13:59:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-10-2020 08:50:27
(UTC-03:00) City ofACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889459
Page 160 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
Nov-10-2020 08:50:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESTranscription Error
Nov-09-2020 21:02:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY: Per
FUP tab, it appears
this AE led to the
subject discontinuing
participation in the
study. If this is correct,
please review this
field to see if should
be updated to 'yes'
Nov-09-2020 12:02:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY: Per
FUP tab, it appears
this AE led to the
subject discontinuing
participation in the
study. If this is correct,
please review this
field to see if should
be updated to 'yes'
Oct-14-2020 09:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0889460
Page 161 of 164
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Oct-06-2020 17:12:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0889461
Page 162 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-10-2020 12:52:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Nov-10-2020 12:50:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged Information
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-06-2020 17:13:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-30-2020 12:33:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-30-2020 12:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-10-2020 12:52:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/5/2020Changed Information
Nov-10-2020 12:50:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/5/2020Changed Information
Oct-15-2020 16:11:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Oct-06-2020 17:13:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Aug-30-2020 12:33:59
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/30/2020Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889462
Page 163 of 164
***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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Buenos Aires
Aug-30-2020 12:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/30/2020Initial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0889463
Page 164 of 164
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12315429 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:43
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 17:53:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ea3\Final\Final On: 01-Apr-2021 03:19 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0889464