125742 S1 M5 CRF c4591001 1231 12313998

Document text

Page 1 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment
5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879453
Page 2 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879454
Page 3 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12313998]
2.Birth Date: /1980
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879455
Page 4 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879456
Page 5 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879457
Page 6 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879458
Page 7 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anemia]
Start Date: Aug/15/2015
Ongoing: YES
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879459
Page 8 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [59.0]
3.Unit: kg
4.Height: [147.0]
5.Unit: cm
6.Body Mass Index: [27.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879460
Page 9 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/25/2020
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:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879461
Page 10 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [66592]
3.Randomization Group: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879462
Page 11 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BJ4BC7]
5.bSample ID [BJ4BC8]
5.cSample ID [BJ4BC9]
5.dSample ID [BPT8Y5]
5.eSample ID [BPT8Y6]
5 fSample ID [BPT8Y7]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879463
Page 12 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BP2F87]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879464
Page 13 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/25/2020 18:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879465
Page 14 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879466
Page 15 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879467
Page 16 of 276
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879468
Page 17 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
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:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879469
Page 18 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BP1RD3]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879470
Page 19 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 15:20
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
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879471
Page 20 of 276
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879472
Page 21 of 276
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
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 [BP1NLR]
5.bSample ID [BRXS5K]
5.cSample ID [BRXS6F]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879473
Page 22 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879474
Page 23 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/7/2020
2.Date of First Symptom Started: Oct/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/13/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879475
Page 24 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879476
Page 25 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/7/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879477
Page 26 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/7/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ATILA BIOSYSTEMS IAMP COVID-19 DETECTION KIT
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879478
Page 27 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Sample collected by team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879479
Page 28 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BPXWY2]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879480
Page 29 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879481
Page 30 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879482
Page 31 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879483
Page 32 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879484
Page 33 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879485
Page 34 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical Eve
nt:Subcategory of Clinical Eve
ntDiagnosis Obtain
edToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879486
Page 35 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879487
Page 36 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879488
Page 37 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879489
Page 38 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879490
Page 39 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879491
Page 40 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879492
Page 41 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879493
Page 42 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879494
Page 43 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879495
Page 44 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879496
Page 45 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879497
Page 46 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879498
Page 47 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879499
Page 48 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879500
Page 49 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879501
Page 50 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879502
Page 51 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/4/2020
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 [BJ5NJJ]
5.bSample ID [BPTC7P]
5.cSample ID [BJ5NHN]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879503
Page 52 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879504
Page 53 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879505
Page 54 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879506
Page 55 of 276
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879507
Page 56 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879508
Page 57 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879509
Page 58 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879510
Page 59 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879511
Page 60 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879512
Page 61 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879513
Page 62 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879514
Page 63 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879515
Page 64 of 276
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879516
Page 65 of 276
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879517
Page 66 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879518
Page 67 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/20/2021
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879519
Page 68 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.aDescription of Exclusion
Criterion MetNot Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879520
Page 69 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879521
Page 70 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/20/2021
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:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879522
Page 71 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/20/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLBXKY]
5.bSample ID [BR21GZ]
5.cSample ID [BLBXJM]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879523
Page 72 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/20/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRM9F2]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879524
Page 73 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/20/2021 11:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879525
Page 74 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879526
Page 75 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/12/2021
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:
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879527
Page 76 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1P97]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879528
Page 77 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/12/2021 17:53
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879529
Page 78 of 276
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879530
Page 79 of 276
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879531
Page 80 of 276
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879532
Page 81 of 276
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879533
Page 82 of 276
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879534
Page 83 of 276
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879535
Page 84 of 276
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879536
Page 85 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. DELETED ADVERSE
EVENT 1  dry cough, malaise, asth
enia and headache. Oct/6/2020
12:00 NO
End Date Time:
Oct/13/2020 12:00
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  general discomfort  Oct/6/2020
12:00 NO
End Date Time:
Oct/13/2020 12:00
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  asthenia  Oct/6/2020
12:00 NO
End Date Time:
Oct/13/2020 12:00
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  headache  Oct/6/2020
12:00 NO
End Date Time:
Oct/13/2020 12:00
 Repeating
Pages
 5. DELETED ADVERSE
EVENT 5  Pregnancy  Dec/25/20
20 11:00 NO
End Date Time:
Jan/28/2021 13:00
 Repeating
Pages
 6. ADVERSE
EVENT 6  Complete spontaneous a
bortion Jan/24/202
1 11:00 NO
End Date Time:
Feb/8/2021 UNK:
UNK
 Repeating
Pages
 7. ADVERSE
EVENT 7  Drug exposed pregnanc
y Dec/25/20
20 11:00 NO
End Date Time:
Jan/28/2021 13:00
 Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879537
Page 86 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 8. DELETED ADVERSE
EVENT 8  Incomplete spontaneous
abortion Jan/24/202
1 11:00 YES  Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879538
Page 87 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[dry cough, malaise, asthenia and headache. ]
4.Start Date Time: Oct/6/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/13/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879539
Page 88 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[tos seca, malestar general, astenia y cefalea. ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879540
Page 89 of 276
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[general discomfort ]
4.Start Date Time: Oct/6/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/13/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879541
Page 90 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[general discomfort ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879542
Page 91 of 276
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[asthenia]
4.Start Date Time: Oct/6/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/13/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879543
Page 92 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[asthenia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879544
Page 93 of 276
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[headache]
4.Start Date Time: Oct/6/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/13/2020 12:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879545
Page 94 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[headache]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879546
Page 95 of 276
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pregnancy ]
4.Start Date Time: Dec/25/2020 11:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/28/2021 13:00
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879547
Page 96 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879548
Page 97 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Complete spontaneous abortion]
4.Start Date Time: Jan/24/2021 11:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/8/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879549
Page 98 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021075742]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879550
Page 99 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Drug exposed pregnancy]
4.Start Date Time: Dec/25/2020 11:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/28/2021 13:00
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879551
Page 100 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879552
Page 101 of 276
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Incomplete spontaneous abortion ]
4.Start Date Time: Jan/24/2021 11:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879553
Page 102 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[it is unknown ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021075742 ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879554
Page 103 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879555
Page 104 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879556
Page 105 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879557
Page 106 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879558
Page 107 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879559
Page 108 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879560
Page 109 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879561
Page 110 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879562
Page 111 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879563
Page 112 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879564
Page 113 of 276
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/16/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879565
Page 114 of 276
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879566
Page 115 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879567
Page 116 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879568
Page 117 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0879569
Page 118 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-17-2021 00:37:32 (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.
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879570
Page 119 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-25-2020 19:40:58 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879571
Page 120 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormJan-27-2021 12:43:37 (UTC-03:00) City of
Buenos Aires
FormAug-25-2020 19:41:22 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879572
Page 121 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormFeb-21-2021 11:37:20 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879573
Page 122 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Jan-30-2021 10:46:40 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879574
Page 123 of 276
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6Feb-23-2021 12:16:31 (UTC-03:00) City of
Buenos AiresAdolfo Gonzalez Not Applicable
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879575
Page 124 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-17-2021 00:37:32 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-13-2021 10:38:11 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-12-2021 10:13:31 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-16-2021 20:09:38 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879576
Page 125 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
N/A
 Approved Feb-11-2021 07:22:58 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-08-2021 17:16:56 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Feb-08-2021 17:13:25 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-05-2021 13:53:37 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-04-2021 18:24:03 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879577
Page 126 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-02-2021 11:05:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-31-2021 14:42:52 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-26-2021 12:19:33 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-20-2021 20:54:30 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) 
(6)
(b) (6)
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879578
Page 127 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-16-2021 20:27:28 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-05-2020 15:50:53 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-05-2020 09:48:36 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-04-2020 16:41:02 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879579
Page 128 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-04-2020 11:16:42 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-23-2020 14:32:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879580
Page 129 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020 19:40:10
(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-25-2020 19:40:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879581
Page 130 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 19:40:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/25/2020Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879582
Page 131 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020 16:24:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12313998Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 16:24:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1980Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 19:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 19:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020 19:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879583
Page 132 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 19:40:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879584
Page 133 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020 19:41:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 19:41:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 19:41:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879585
Page 134 of 276
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - 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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Jan-27-2021 12:44:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Anemia
Start Date: Aug/15/20
15
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-27-2021 12:44:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-27-2021 12:44:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
AnemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Jan-27-2021 12:44:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-27-2021 12:44:29
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879586
Page 135 of 276
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - 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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879587
Page 136 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
59.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
147.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879588
Page 137 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.3Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 36.9
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879589
Page 138 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 19:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879590
Page 139 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879591
Page 140 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-25-2020 19:41:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879592
Page 141 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 19:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 19:42:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
66592Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879593
Page 142 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 19:42:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 19:42:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 09:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 02:54:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 19:42:15
(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-25-2020 19:42:15
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879594
Page 143 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Aug/25/2020
5.a
Date Location User Value Reason
Aug-26-2020 09:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ4BC7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 09:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ4BC7Initial Entry
5.b
Date Location User Value Reason
Aug-26-2020 09:09:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ4BC8Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 09:09:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ4BC8Initial Entry
5.c
Date Location User Value Reason
Aug-26-2020 09:09:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BJ4BC9Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879595
Page 144 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 09:09:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BJ4BC9Initial Entry
5.d
Date Location User Value Reason
Aug-26-2020 18:26:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT8Y5Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020 18:26:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT8Y5Initial Entry
5.e
Date Location User Value Reason
Aug-26-2020 18:26:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT8Y6Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020 18:26:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT8Y6Initial Entry
5.f
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879596
Page 145 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-26-2020 18:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT8Y7Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-26-2020 18:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT8Y7Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879597
Page 146 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 19:42:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 19:42:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 09:34:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 02:54:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 19:42:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 19:42:21
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879598
Page 147 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Aug/25/2020
5.a
Date Location User Value Reason
Aug-26-2020 09:34:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2F87Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 09:34:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2F87Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879599
Page 148 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/25/2020 18:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879600
Page 149 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 19:42:33
(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-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-25-2020 19:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879601
Page 150 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020 19:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879602
Page 151 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 19:00:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/15/2020Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879603
Page 152 of 276
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Identifie
r::1
Temperature: 36.8
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879604
Page 153 of 276
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879605
Page 154 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879606
Page 155 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 19:00:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879607
Page 156 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 08:42:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 08:42:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 08:42:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 08:42:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 08:42:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879608
Page 157 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-16-2020 08:42:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BP1RD3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 08:42:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BP1RD3Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879609
Page 158 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/15/2020 15:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879610
Page 159 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-17-2020 19:01:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879611
Page 160 of 276
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 12:14:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0879612
Page 161 of 276
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 10:08:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 10:08:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 10:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 10:08:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 10:08:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879613
Page 162 of 276
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-15-2020 10:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID: BP1NLRInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 10:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BP1NLRInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXS5KInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRXS5KInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 12:06:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRXS6FInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879614
Page 163 of 276
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 12:06:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRXS6FInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879615
Page 164 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-13-2020 13:00:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-12-2020 12:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 12:35:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-12-2020 12:35:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879616
Page 165 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-12-2020 12:35:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Oct/7/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-12-2020 12:35:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879617
Page 166 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-14-2020 15:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Res
olved:
Oct/13/2020New Information
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Res
olved:
Oct/8/2020Initial Entry
4.a
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879618
Page 167 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.a Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCR
EASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879619
Page 168 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Pres
ent:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879620
Page 169 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.d Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879621
Page 170 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF T
ASTE OR SMEL
L
Sympto
m Presen
t:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879622
Page 171 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.g Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879623
Page 172 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-16-2020 11:42:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-16-2020 11:10:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
Oct-15-2020 17:33:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CRA: according
to medical note,
subject presented
as well asthenia
and cephalea.
Please include.
Thanks.
Oct-14-2020 12:27:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879624
Page 173 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879625
Page 174 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879626
Page 175 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEMS IAM
P COVID-19 DETECTION
KITInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-14-2020 12:28:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879627
Page 176 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 12:29:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 12:29:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 12:29:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-14-2020 12:29:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by team phy
sicianInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879628
Page 177 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 12:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 12:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 12:36:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 12:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-12-2020 12:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879629
Page 178 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-12-2020 12:36:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BPXWY2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 12:36:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BPXWY2Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879630
Page 179 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879631
Page 180 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879632
Page 181 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879633
Page 182 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879634
Page 183 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-14-2020 12:30:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879635
Page 184 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/07/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-14-2020 12:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNE
SSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-14-2020 12:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-14-2020 17:42:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879636
Page 185 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-04-2020 11:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-04-2020 11:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879637
Page 186 of 276
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 11:16:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 11:16:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 09:48:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 11:16:51
(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.
Nov-04-2020 11:16:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879638
Page 187 of 276
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-05-2020 09:48:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ5NJJInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 09:48:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5NJJInitial Entry
5.b
Date Location User Value Reason
Nov-05-2020 10:00:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTC7PInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-05-2020 10:00:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTC7PInitial Entry
5.c
Date Location User Value Reason
Nov-05-2020 10:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ5NHNInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-05-2020 10:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5NHNInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879639
Page 188 of 276
***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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 12:14:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 12:14:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 12:14:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879640
Page 189 of 276
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-16-2021 20:27:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879641
Page 190 of 276
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-16-2021 20:27:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-16-2021 20:27:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-16-2021 20:27:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to retu
rn for Vaccination 3
Participant is:
eligible per local/nationa
l recommendations and c
onfirmed to have receive
d only placebo at Vaccin
ation 1/2Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0879642
Page 191 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-21-2021 11:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/20/2021New Information
Jan-26-2021 12:56:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/25/2021Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879643
Page 192 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-21-2021 11:35:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-21-2021 11:35:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtain
ed
Feb/20/2021New Information
Feb-21-2021 11:32:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained
is not the same as
the Date of Visit.
Please correct as
necessary.
Jan-26-2021 12:56:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtain
ed
Jan/25/2021Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879644
Page 193 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
2.a
Date Location User Value Reason
Feb-21-2021 11:36:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Criterion Description:New Information
Jan-26-2021 12:57:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Criterion
Descripti
on:Women who are p
regnant or breastf
eedingInitial Entry
2.a Description of Exclusion Criterion Met
Date Location User Value Reason
Feb-21-2021 11:36:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry: New Information
Jan-28-2021 05:15:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Per site
confirmation_PD
tracker updated
Jan-27-2021 10:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
Jan-27-2021 03:04:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened PDQ: An Exclusion
'Criterion Met' is
recorded as YES,
and the 'Status' on
the Disposition -
Screening form is
not SCREEN
FAILURE. Please
review and correct
or confirm.
Jan-26-2021 12:57:28
(UTC-03:00) City ofACV0PFEINFP6000  Martina
DavalliData Entry:
Women who are pregnant orInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879645
Page 194 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires breastfeeding
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879646
Page 195 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-21-2021 11:37:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/20/2021New Information
Jan-26-2021 12:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/25/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-26-2021 12:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-21-2021 11:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-21-2021 11:37:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Status" is
COMPLETED but
"Specify Status" is
Provided.
Feb-21-2021 11:37:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
COMPLETEDNew Information
Jan-26-2021 12:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879647
Page 196 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Jan-26-2021 12:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to
"Status" is NO
LONGER MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Jan-26-2021 12:57:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO LONGER MEETS ELIGI
BILITY CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-21-2021 11:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry: New Information
Jan-26-2021 12:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
The volunteer is pregnantInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879648
Page 197 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/20/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879649
Page 198 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Feb-21-2021 11:38:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879650
Page 199 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-21-2021 11:38:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-21-2021 11:38:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021 09:00:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 08:29:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-21-2021 11:38:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-21-2021 11:38:37
(UTC-03:00) City ofACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879651
Page 200 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Feb/20/2021
5.a
Date Location User Value Reason
Feb-22-2021 09:00:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLBXKYInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-22-2021 09:00:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLBXKYInitial Entry
5.b
Date Location User Value Reason
Feb-22-2021 09:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR21GZInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-22-2021 09:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR21GZInitial Entry
5.c
Date Location User Value Reason
Feb-22-2021 13:12:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBXJMInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879652
Page 201 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Feb-22-2021 13:12:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBXJMInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879653
Page 202 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-21-2021 11:38:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-21-2021 11:38:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021 09:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 08:29:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-21-2021 11:38:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-21-2021 11:38:49
(UTC-03:00) City ofACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879654
Page 203 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Date of Collection:
Feb/20/2021
5.a
Date Location User Value Reason
Feb-22-2021 09:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRM9F2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-22-2021 09:05:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRM9F2Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879655
Page 204 of 276
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Feb/20/2021 11:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879656
Page 205 of 276
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-21-2021 11:39:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0879657
Page 206 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-13-2021 10:38:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879658
Page 207 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879659
Page 208 of 276
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Mar-13-2021 10:38:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879660
Page 209 of 276
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 12313998 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-13-2021 10:39:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-13-2021 10:39:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-13-2021 11:55:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-13-2021 10:39:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-13-2021 10:39:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2e99\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0879661
Page 210 of 276
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Froz
…[truncated]