125742 S1 M5 CRF c4591001 1231 12314075

Document text

Page 1 of 267
***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: 12314075 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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880697
Page 2 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880698
Page 3 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314075]
2.Birth Date: /1994
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880699
Page 4 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880700
Page 5 of 267
***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: 12314075 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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880701
Page 6 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880702
Page 7 of 267
***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: 12314075 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:[HERNIATED DISC L3 L4 AND L5]
Start Date: Jun/1/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC LOW BACK PAIN]
Start Date: Jun/1/2019
Ongoing: YES
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880703
Page 8 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [76.45]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [25.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880704
Page 9 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [67115]
3.Randomization Group: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880705
Page 10 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNVBPP]
5.bSample ID [BNVBPR]
5.cSample ID [BPT96W]
5.dSample ID [BPT96X]
5.eSample ID [BPT96Y]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880706
Page 11 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2FBS]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880707
Page 12 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 09:10
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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880708
Page 13 of 267
***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: 12314075 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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880709
Page 14 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880710
Page 15 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880711
Page 16 of 267
***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: 12314075 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/17/2020
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 [BPW9ZC]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880712
Page 17 of 267
***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: 12314075 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/17/2020 11:04
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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880713
Page 18 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880714
Page 19 of 267
***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: 12314075 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/21/2020
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 [BPTHR4]
5.bSample ID [BJ5MNZ]
5.cSample ID [BJ5MNM]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880715
Page 20 of 267
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880716
Page 21 of 267
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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:
Mar/22/2021
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 [BP1WYJ]
5.bSample ID [BS1PLY]
5.cSample ID [BS1PYP]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880717
Page 22 of 267
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880718
Page 23 of 267
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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 [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880719
Page 24 of 267
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880720
Page 25 of 267
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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 [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880721
Page 26 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880722
Page 27 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/12/2021
2.Date of First Symptom Started: Mar/5/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Mar/9/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
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? NO
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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880723
Page 28 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880724
Page 29 of 267
***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: 12314075 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.Mar/12/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0880725
Page 30 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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: Mar/12/2021
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: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880726
Page 31 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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 a team physician]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880727
Page 32 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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 [BR2205]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880728
Page 33 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880729
Page 34 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Mar/6/2021  NO
Discharge Date:
Mar/10/2021
 Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880730
Page 35 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Mar/6/2021
4.Ongoing? NO
Discharge Date:
Mar/10/2021
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880731
Page 36 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880732
Page 37 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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?
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880733
Page 38 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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?YES
Respiratory Illness Diagnosis:
[cholestatic syndrome]
Date of Diagnosis:
Mar/6/2021
3.Toxicity Grade: 2
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880734
Page 39 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880735
Page 40 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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:
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880736
Page 41 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category f
or Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.CLINICAL
CHEMIST
RY Sanatorio de la Providencia -
Tucuman St. #1863 Buenos
Aires City. Mar/10/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Pro
tein_PX329 [ ] 
30  Alanine Amin
otransferase_P
X30 53.
6 
28  Aspartate Ami
notransferase_
PX28 33.
1 
35  Alkaline Phosp
hatase_PX35 205
.5 
21  Bilirubin_PX2
1 1.5
8 
47  Blood Urea Ni
trogen_PX47 24 
48  Creatinine_PX
48 0.8
5 Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880737
Page 42 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Sanatorio de la Providencia - Tucuman St. #1863 Buenos Aires City.]
3.Collection Date: Mar/10/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [53.6]
Not Done:
LNMT Low
[not reported]
High
[40]
Unit
U/L
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880738
Page 43 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [33.1]
Not Done:
LNMT Low
[not reported]
High
[38]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [205.5]
Not Done:
LNMT Low
[70]
High
[300]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [1.58]
Not Done:
LNMT Low
[not reported]
High
[2]
Unit
mg/dL
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880739
Page 44 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [24]
Not Done:
LNMT Low
[10]
High
[50]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.85]
Not Done:
LNMT Low
[0.50]
High
[1.20]
Unit
mg/dL
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880740
Page 45 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category f
or Lab Tes
tVendor Name (DERIVED)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.HEMATO
LOGY Sanatorio de la Providencia - T
ucuman St. #1863 Buenos Aire
s City. Mar/10/
2021 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
1  Hemoglob
in_PX1 15.
6 
2  Hematocri
t_PX2 45 
3  Erythrocyt
es_PX3 [ ] 
5  Platelets_
PX5 167
.3 
7  Leukocyte
s_PX7 6.9 
608  Neutrophil
s_PX608 [ ] 
609  Eosinophil
s_PX609 [ ] 
612  Monocyte
s_PX612 [ ] 
610  Basophils
_PX610 [ ] 
611  Lymphocy
tes_PX611
 [ ] Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880741
Page 46 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Sanatorio de la Providencia - Tucuman St. #1863 Buenos Aires City.]
3.Collection Date: Mar/10/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [15.6]
Not Done:
LNMT Low
[13]
High
[16]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [45]
Not Done:
LNMT Low
[40]
High
[50]
Unit
%
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880742
Page 47 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [167.3]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [6.9]
Not Done:
LNMT Low
[4]
High
[10]
Unit
10^3/uL
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880743
Page 48 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880744
Page 49 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880745
Page 50 of 267
***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: 12314075 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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880746
Page 51 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880747
Page 52 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880748
Page 53 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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 % [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880749
Page 54 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880750
Page 55 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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):[ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880751
Page 56 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880752
Page 57 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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?
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880753
Page 58 of 267
***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: 12314075 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.Mar/10/2021  OTHER
If other, specify:
pancreatic hepato biliary
 ULTRASOUND  INDETERMINATE  Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880754
Page 59 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Mar/10/2021
2.Location of Assessment: OTHER
If other, specify:
[pancreatic hepato biliary]
3.Type of Imaging Exam: ULTRASOUND
4.Assessment: INDETERMINATE
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880755
Page 60 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880756
Page 61 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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 [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880757
Page 62 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880758
Page 63 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880759
Page 64 of 267
***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: 12314075 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880760
Page 65 of 267
***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: 12314075 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: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880761
Page 66 of 267
***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: 12314075 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:
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880762
Page 67 of 267
***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: 12314075 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 [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880763
Page 68 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880764
Page 69 of 267
***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: 12314075 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:
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880765
Page 70 of 267
***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: 12314075 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?
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880766
Page 71 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880767
Page 72 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880768
Page 73 of 267
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/6/2021
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880769
Page 74 of 267
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/6/2021
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880770
Page 75 of 267
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 12314075 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/6/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS440L]
5.bSample ID [BS4406]
5.cSample ID [BPTHBT]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880771
Page 76 of 267
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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/6/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWDD9]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880772
Page 77 of 267
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/16/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880773
Page 78 of 267
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/16/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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/16/2021
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 [BR1N5L]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880774
Page 79 of 267
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/03/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880775
Page 80 of 267
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 2 - Unscheduled
Visit on Mar/03/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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/3/2021
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 [BRMD0H]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880776
Page 81 of 267
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 - Unscheduled
Visit on Mar/22/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK6
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880777
Page 82 of 267
***Confidential***
 
Header Text: C4591001
Visit: V202_SURVEIL_SWAB 3 - Unscheduled
Visit on Mar/22/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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/22/2021
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 [BP887Y]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880778
Page 83 of 267
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880779
Page 84 of 267
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880780
Page 85 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  NOCTURNE POLLAKIURI
A Aug/28/2020
09:00 NO
End Date Time:
Oct/28/2020 17:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  LOW BACK PAIN WORSE
NING Aug/30/2020
09:00 NO
End Date Time:
Sep/22/2020 20:00
 Repeating
Pages
 3.ADVERSE E
VENT 3  Cholestatic syndrome second
ary to lithiasis Mar/5/2021 0
9:00 NO
End Date Time:
Mar/10/2021 12:00
 Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880781
Page 86 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[NOCTURNE POLLAKIURIA]
4.Start Date Time: Aug/28/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 17:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880782
Page 87 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880783
Page 88 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[LOW BACK PAIN WORSENING]
4.Start Date Time: Aug/30/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/22/2020 20:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[underlying disc pathology]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880784
Page 89 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880785
Page 90 of 267
***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: 12314075 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Cholestatic syndrome secondary to lithiasis]
4.Start Date Time: Mar/5/2021 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/10/2021 12:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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?
YES
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
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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880786
Page 91 of 267
***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: 12314075 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:
[lithiasis]
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[2021273286]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880787
Page 92 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880788
Page 93 of 267
***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: 12314075 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[ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880789
Page 94 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880790
Page 95 of 267
***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: 12314075 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: //
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880791
Page 96 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880792
Page 97 of 267
***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: 12314075 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?
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880793
Page 98 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880794
Page 99 of 267
***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: 12314075 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?
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880795
Page 100 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880796
Page 101 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880797
Page 102 of 267
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880798
Page 103 of 267
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880799
Page 104 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880800
Page 105 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880801
Page 106 of 267
***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: 12314075 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: [ ]
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880802
Page 107 of 267
***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: 12314075 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/21/2020
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880803
Page 108 of 267
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880804
Page 109 of 267
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880805
Page 110 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-26-2020 12:01:41 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880806
Page 111 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormSep-23-2020 13:10:46 (UTC-03:00) City of
Buenos Aires
FormAug-26-2020 12:02:05 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880807
Page 112 of 267
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-22-2021 13:47:45 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-19-2021 18:34:28 (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-05-2021 11:22:24 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-04-2021 17:20:52 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880808
Page 113 of 267
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Martina
Davalli N/A Mar-04-2021 10:31:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-17-2021 20:25:09 (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 19:24:44 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-11-2021 07:19:18 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880809
Page 114 of 267
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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-09-2021 09:33:38 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-08-2021 21:53:31 (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-07-2021 21:13:09 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Nov-04-2020 11:50:22 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880810
Page 115 of 267
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Tatiana Estrada  N/A Nov-03-2020 13:49:28 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-30-2020 20:48:26 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-30-2020 11:17:17 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-29-2020 13:42:05 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880811
Page 116 of 267
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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.
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880812
Page 117 of 267
***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: 12314075 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-26-2020 12:01:06
(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-26-2020 12:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880813
Page 118 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 12:01:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/26/2020Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880814
Page 119 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 08:45:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314075Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 08:45:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1994Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 12:01:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 12:01:22
(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-26-2020 12:01:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880815
Page 120 of 267
***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: 12314075 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-26-2020 12:01:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880816
Page 121 of 267
***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: 12314075 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-26-2020 12:01:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 12:01:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 12:01:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880817
Page 122 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:HERNIATED DI
SC L3 L4 AND L
5
Start Date: Jun/1/2019
Ongoing: YESInitial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
Nov-03-2020 13:49:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana
EstradaData Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:herniated disc
L3, L4 , L5
Start Date: Jun/1/2019
Ongoing: YESChanged
Information
Sep-23-2020 13:11:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:LOW BACK
PAIN
Start Date: Jun/1/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-04-2020 09:51:58 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880818
Page 123 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos Aires(autocalc) 1
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 13:11:35
(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
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HERNIATED DISC L3 L4 A
ND L5Initial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-03-2020 13:49:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Data Entry:
herniated disc L3, L4 , L5Changed
Information
Sep-29-2020 17:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-29-2020 13:48:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered This medical
history term is
LOW BACK
PAIN. Thank you.
Sep-24-2020 14:46:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if Med
History term is
accurate.
According to the
AE record, subject
had AE of 'low
back pain' due to
'Symptoms due to
its underlying disc
pathology'. Is term
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880819
Page 124 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
'low back pain' or
'underlying disc
pathology'. Please
update record.
Sep-23-2020 13:11:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LOW BACK PAINInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/1/2019Initial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 13:11:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/1/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 13:11:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N 2Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880820
Page 125 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires umber:
Medical His
tory Term:CHRONIC LO
W BACK PAIN
Start Date: Jun/1/2019
Ongoing: YES
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana
EstradaData Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Herniated disc
L3 L4 and L5
Start Date: Sep/21/2020
Ongoing: YESChanged
Information
(DELETED)
Oct-30-2020 11:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Herniated disc
L3 L4 and L5
Start Date: Sep/21/2020
Ongoing: YESNew Information
Oct-28-2020 10:50:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:herniated lum
bar disc
Start Date: Jun/1/2019
Ongoing: YESTranscription Error
Sep-29-2020 18:50:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:herniated lum
bar discNew Information
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880821
Page 126 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Start Date: Sep/21/2020
Ongoing: YES
Sep-24-2020 16:27:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:herniated lum
bar disc
Start Date: Sep/3/2020
Ongoing: YESInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880822
Page 127 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Line/MH Number:
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Itemset row was
undeleted in order
to clear CRF
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana
EstradaData Entry:
2Changed
Information
(DELETED)
Sep-24-2020 16:27:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHRONIC LOW BACK PAI
NInitial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Itemset row was
undeleted in order
to clear CRF
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Data Entry:
Herniated disc L3 L4 and L5Changed
Information
(DELETED)
Nov-03-2020 11:47:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Follow-up query
entered to move
event to AE record
since start date is
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880823
Page 128 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
after signing of
Informed Consent.
Nov-03-2020 08:48:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Noted
start date is after IC
which is not
permitted. The date
that the surgery
was decided (not
the date the surgery
took place) must be
used as the ‘start
date’ in the med hx
CRF. Please review
and update.
Nov-03-2020 08:47:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Luke Cunliffe Query 1: Candidate ClinQuery: Noted
start date is after IC
which is not
permitted. The date
that the surgery
was decided (not
the date the surgery
took place) must be
used as the ‘start
date’ in the med hx
CRF. Please review
and update.
Oct-30-2020 11:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Herniated disc L3 L4 and L5New Information
Sep-24-2020 16:27:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
herniated lumbar discInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/1/2019Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880824
Page 129 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Itemset row was
undeleted in order
to clear CRF
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-04-2020 06:28:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 5: Closed Closed as data
removed.
Nov-03-2020 15:05:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Nov-03-2020 14:47:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Adolfo Gonzalez Query 5: Answered Changed data per
query
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Data Entry:
Sep/21/2020Changed
Information
(DELETED)
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Start Date is after
or equal to the first
vaccination date
26/Aug/2020.
Please review and
update as
appropriate.
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Changed
Information
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (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-2021-5683-0880825
Page 130 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.b Start Date:
Date Location User ValueReason
Nov-03-2020
13:28:20
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
4: Rei
ssued:
Opene
dClinQuery: Since
event started after
signing of the
informed consent,
please move event
to AE record. Also,
since event has
been diagnosed,
please update
symptom term
'back pain' to
medical diagnosis
'herniated disc L3,
L4, L5' with onset
date.
Nov-03-2020
12:11:27
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Query
4: An
swere
dthe back pain in
medical history has
now a diagnosis:
herniated disc L3,
L4, L5. Do you
think we should
change the start
date in this event
and associate it to
he first AE "back
pain"? thank you.
Nov-03-2020
11:49:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
4: Op
enedClinQuery:
Medical History
event 'herniated
disc L3, L4, L5'
has start date that is
after the subject
signed Informed
Consent. Please
confirm start date
of event. If
confirmed after
signing of
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880826
Page 131 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Informed Consent,
please move event
to AE record.
Oct-31-2020
10:28:38
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies
query
Oct-30-2020
15:52:53
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Query
3: An
swere
dThe start date is
correct, that day
the subject
received by his
doctor the final
diagnosis, that was
the cause of the
pain that was under
investigation at the
time the subject
received first
vaccination. thank
you
Oct-30-2020
11:34:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query
3: Op
enedStart Date is after
or equal to the first
vaccination date
26/Aug/2020.
Please review and
update as
appropriate.
Oct-30-2020
11:34:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Sep/2
1/202
0New Information
Oct-28-2020
15:50:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Oct-28-2020 ACV0PFEINFP6000  auto query QueryAnswer Auto
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880827
Page 132 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
10:50:35
(UTC-03:00)
City of
Buenos Aires(autoquery) 1: An
swere
dQuery
Oct-28-2020
10:50:35
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Jun/1/
2019Transcription Error
Oct-27-2020
16:42:10
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dIf condition started
before the
screening period
then kindly update
start date on this
page
Oct-26-2020
11:57:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Maria Beretta Query
1: An
swere
dAs the pain started
before, we can
asume that the
hernias were
present before the
consent was given.
Only the MRI
diagnosis was done
after. Thank you
Oct-23-2020
04:53:54
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM2: Thanks for
response. If
condition started
before the
screening period
then kindly update
start date on this
page. If condition
started after the
first vaccination
date , then consider
moving event to
‘Adverse Event’
CRF per protocol
instructions.
Oct-21-2020
11:07:26ACV0PFEINFP6000  Query
1: AnThe volunteer
presents low back
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880828
Page 133 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00)
City of
Buenos Airesswere
dpain prior to his
visit 1, and the
diagnosis of
herniated disc was
made later, this
being the etiology
of his low back
pain (it is not an
adverse event)
Oct-20-2020
01:50:55
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM 1: Start date
(21/Sep/2020) is
after the First dose
date (26/Aug
/2020). Thus,
Please review and
consider to move
this record to
ADVERSE
EVENT log form.
Else, clarify.
Oct-19-2020
13:57:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: An
swere
dAn adverse event
was uploaded for
this condition
Thank you
Oct-19-2020
10:48:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Clo
sedAnother query
present for same
issue
Oct-08-2020
08:17:51
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Rei
ssued:
Candi
dateas another query
reissued on start
date of MH.
Oct-08-2020
08:17:14
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM1: Thanks for
your response. If
condition started
before the
screening period
then kindly update
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (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-2021-5683-0880829
Page 134 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
start date on this
page. If condition
started after the
first vaccination
date, then consider
moving event to
‘Adverse Event’
CRF per protocol
instructions.
Oct-06-2020
09:04:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: An
swere
dSubject forgot to
mention a chronic
low back pain of
unknown cause
since June 2019, so
on 2020-sep-3 a
spinal MRI was
performed.
Diagnosis: L3-L4
and L5-S1 disc
herniation, reported
to the volunteer by
his traumatologist
on 2020-sep-21.
Oct-06-2020
09:03:46
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: An
swere
dSubject forgot to
mention a chronic
low back pain of
unknown cause
since June 2019, so
on 2020-sep-3 a
spinal MRI was
performed.
Diagnosis: L3-L4
and L5-S1 disc
herniation, reported
to the volunteer by
his traumatologist
on 2020-sep-21.
Oct-05-2020
04:59:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dDM : For AE
(herniated lumbar
disc): Start date
(21/Sep/2020) is
after the first
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880830
Page 135 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
vaccination dose
date (26/Aug
/2020). If date is
correct, consider
moving event to
the Adverse Event
CRF per protocol
instructions
Oct-05-2020
04:57:52
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM : For AE
(herniated lumbar
disc): Start date
(21/Sep/2020) is
after the first
vaccination dose
date (26/Aug
/2020). Please
review and update
the data with the
help of CRA. Else,
clarify.
Oct-01-2020
13:31:34
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: An
swere
dSubject forgot to
mention a chronic
low back pain of
unknown cause
since June 2019, so
on 2020-sep-3 a
spinal MRI was
performed.
Diagnosis: L3-L4
and L5-S1 disc
herniation, reported
to the volunteer by
his traumatologist
on 2020-sep-21.
Oct-01-2020
13:31:13
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: An
swere
dSubject forgot to
mention a chronic
low back pain of
unknown origin
since June 2019, so
on 2020-sep-3 a
spinal MRI was
performed.
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880831
Page 136 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Diagnosis: L3-L4
and L5-S1 disc
herniation, reported
to the volunteer by
his traumatologist
on 2020-sep-21.
Sep-29-2020
22:22:46
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Rei
ssued:
Opene
dReopen: The
Medical History
condition 'Start
Date' is after the
first study
treatment 'Start
Date'. Please
review. If date is
correct, consider
moving event to
the Adverse Event
CRF per protocol
instructions.
Sep-29-2020
18:50:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dNew Information
Sep-29-2020
18:50:50
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Sep/2
1/202
0New Information
Sep-24-2020
22:15:52
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW4814252;The
Medical History
condition 'Start
Date' is after the
first study
treatment 'Start
Date'. Please
review. If date is
correct, consider
moving event to
the Adverse Event
CRF per protocol
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880832
Page 137 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
instructions.
Sep-24-2020
16:27:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedStart Date is after
or equal to the first
vaccination date
26/Aug/2020.
Please review and
update as
appropriate.
Sep-24-2020
16:27:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Sep/3/
2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-04-2020 09:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Itemset row was
undeleted in order
to clear CRF
Nov-04-2020 09:45:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Nov-03-2020 13:50:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Tatiana
EstradaData Entry:
YESChanged
Information
(DELETED)
Sep-24-2020 16:27:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880833
Page 138 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
76.45Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
172.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (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-2021-5683-0880834
Page 139 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.8Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.5
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880835
Page 140 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-26-2020 12:02:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880836
Page 141 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 12:02:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 12:02:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
67115Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880837
Page 142 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 12:03:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 12:03:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 11:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 12:12:44
(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-26-2020 12:03:01
(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-26-2020 12:03:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880838
Page 143 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Aug-27-2020 11:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNVBPPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 11:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNVBPPInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 11:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNVBPRInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 11:54:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNVBPRInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 13:27:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT96WInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (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-2021-5683-0880839
Page 144 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 13:27:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT96WInitial Entry
5.d
Date Location User Value Reason
Aug-27-2020 13:27:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT96XInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 13:27:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT96XInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020 13:28:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT96YInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 13:28:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT96YInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (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-2021-5683-0880840
Page 145 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 12:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 12:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 15:27:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 12:12:44
(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-26-2020 12:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-26-2020 12:03:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880841
Page 146 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Aug-27-2020 15:27:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP2FBSInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 15:27:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP2FBSInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880842
Page 147 of 267
***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: 12314075 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-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020 09:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880843
Page 148 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-26-2020 12:03:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880844
Page 149 of 267
***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: 12314075 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-26-2020 12:03:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880845
Page 150 of 267
***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: 12314075 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 19:28:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880846
Page 151 of 267
***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: 12314075 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 19:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 19:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.4
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 19:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 19:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 19:28:53
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (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-2021-5683-0880847
Page 152 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 19:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880848
Page 153 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 12:46:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 12:46:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 12:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 12:46:41
(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-17-2020 12:46:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 12:47:11
(UTC-03:00) City ofACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BPW9ZCInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880849
Page 154 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 12:47:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BPW9ZCInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880850
Page 155 of 267
***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: 12314075 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 19:29:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 19:29:06
(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 19:29:06
(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 19:29:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020 11:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 19:29:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880851
Page 156 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020 19:29:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020 19:29:06
(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 19:29:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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 19:29:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880852
Page 157 of 267
***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: 12314075 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-21-2020 11:20:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880853
Page 158 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 11:20:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020 11:20:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 11:58:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 11:20:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 11:20:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 11:58:08
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Sample ID: BPTHR4Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880854
Page 159 of 267
***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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 11:58:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTHR4Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020 12:28:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ5MNZInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 12:28:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5MNZInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 13:11:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ5MNMInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 13:11:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BJ5MNMInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0880855
Page 160 of 267
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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-22-2021 13:47:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/22/2021Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0880856
Page 161 of 267
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-22-2021 13:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-22-2021 13:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021 09:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-22-2021 13:47:56
(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-22-2021 13:47:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/22/2021Initial Entry
5.a
Date Location User Value Reason
Mar-23-2021 09:18:46 ACV0PFEINFP6000  Alan Colombo Data Entry: Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0880857
Page 162 of 267
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresSample ID: BP1WYJ
5.a Sample ID
Date Location User Value Reason
Mar-23-2021 09:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1WYJInitial Entry
5.b
Date Location User Value Reason
Mar-23-2021 10:00:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1PLYInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-23-2021 10:00:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1PLYInitial Entry
5.c
Date Location User Value Reason
Mar-23-2021 13:04:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1PYPInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021 13:04:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1PYPInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0880858
Page 163 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 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-14-2021 10:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-14-2021 10:33:40
(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.
Mar-14-2021 10:33:40
(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.
Mar-14-2021 10:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-14-2021 10:33:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880859
Page 164 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolve
d:
Mar/9/2021Initial Entry
4.a
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880860
Page 165 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.a Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880861
Page 166 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.c Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-14-2021 10:35:16 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880862
Page 167 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresSymptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880863
Page 168 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.f Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880864
Page 169 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Present
:NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880865
Page 170 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4.i Symptoms:
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-14-2021 10:35:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880866
Page 171 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880867
Page 172 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/12/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-14-2021 10:35:40
(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
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880868
Page 173 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ATILA BIOSYSTEMS IAMP C
OVID-19 DETECTION KITInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-14-2021 10:35:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880869
Page 174 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-14-2021 10:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-14-2021 10:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-14-2021 10:36:15
(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
Mar-14-2021 10:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample collected by a team physi
cianInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880870
Page 175 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-14-2021 10:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-14-2021 10:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-15-2021 11:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-15-2021 06:32:46
(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.
Mar-14-2021 10:36:26
(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-14-2021 10:36:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880871
Page 176 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: 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: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Mar-15-2021 11:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample ID: BR2205Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-15-2021 11:23:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BR2205Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880872
Page 177 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880873
Page 178 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880874
Page 179 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880875
Page 180 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Mar-14-2021 10:37:08
(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
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880876
Page 181 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-14-2021 10:37:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensiv
e care due to potential COVID-
19 illness?
NOInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880877
Page 182 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Mar-14-2021 10:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880878
Page 183 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Mar-14-2021 10:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Mar-14-2021 10:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Mar-17-2021 12:30:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-17-2021 10:51:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered All available
information was
loaded. Thank you.
Mar-15-2021 12:34:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Hospitalization:
This subject had
COVID-19 Illness
and was
hospitalized. Please
enter any available
information (vital
signs, pulse oxymet,
respiratory
treatment, lab
results, imaging…).
Please make every
effort to obtain these
information.
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880879
Page 184 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-14-2021 10:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/6/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Mar-14-2021 10:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Mar/10/2021Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880880
Page 185 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 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
Mar-14-2021 10:38:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-14-2021 10:38:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
cholestatic syndrome
Date of Diagnosis:
Mar/6/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Mar-14-2021 10:38:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880881
Page 186 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Audit Trail
Form Version: 21-Aug-2020 02:49 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880882
Page 187 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sanatorio de la Providencia - Tu
cuman St. #1863 Buenos Aires C
ity.Initial Entry
3. Collection Date:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Mar-17-2021 10:45:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:329
Test:: C Reactive Pro
tein_PX329
Result::Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880883
Page 188 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Not Done:: NOT DONE
Lab Normal R
ange:
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Define
d Identifier:
Test:: C Reactive Pro
tein_PX329
Result::
Not Done::
Lab Normal R
ange:Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:45:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Not Done:
Date Location User Value Reason
Mar-17-2021 10:45:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.b
Date Location User Value Reason
Mar-17-2021 10:42:56
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880884
Page 189 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires Sponsor-Defi
ned Identifier
:30
Test:: Alanine Aminotr
ansferase_PX30
Result:: 53.6
Not Done::
Lab Normal
Range:Low
not reported
High
40
Unit
U/L
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifier
:
Test:: Alanine Aminot
ransferase_PX3
0
Result::
Not Done::
Lab Normal
Range:Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880885
Page 190 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Result:
Date Location User Value Reason
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
53.6Initial Entry
5.b LNMT
Date Location User Value Reason
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
not reported
High
40
Unit
U/LInitial Entry
5.c
Date Location User Value Reason
Mar-17-2021 10:43:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie28Transcription Error
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880886
Page 191 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
r:
Test:: Aspartate Amino
transferase_PX2
8
Result:: 33.1
Not Done::
Lab Normal
Range:Low
not reported
High
38
Unit
U/L
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:28
Test:: Aspartate Amin
otransferase_PX
28
Result:: 33.1
Not Done::
Lab Normal
Range:Low
not reported
High
38Initial Entry
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie
r:
Test:: Aspartate Amin
otransferase_PX
28
Result::
Not Done::
Lab Normal
Range:Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880887
Page 192 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aspartate Aminotransferase_PX
28Initial Entry
5.c Result:
Date Location User Value Reason
Mar-17-2021 10:43:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Result is present,
but lab normal
range (Low, high
or Unit) is missing.
Please correct or
confirm.
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
33.1Initial Entry
5.c LNMT
Date Location User Value Reason
Mar-17-2021 10:43:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
not reported
High
38Transcription Error
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880888
Page 193 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unit
U/L
Mar-17-2021 10:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
not reported
High
38Initial Entry
5.d
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:35
Test:: Alkaline Phosph
atase_PX35
Result:: 205.5
Not Done::
Lab Normal R
ange:Low
70
High
300
Unit
U/LInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880889
Page 194 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
205.5Initial Entry
5.d LNMT
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
70
High
300
Unit
U/LInitial Entry
5.e
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:21Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880890
Page 195 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Test:: Bilirubin_P
X21
Result:: 1.58
Not Done::
Lab Normal Range
:Low
not report
ed
High
2
Unit
mg/dL
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880891
Page 196 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.e Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1.58Initial Entry
5.e LNMT
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
not reported
High
2
Unit
mg/dLInitial Entry
5.f
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:47Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880892
Page 197 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Test:: Blood Urea Nitr
ogen_PX47
Result:: 24
Not Done::
Lab Normal Ra
nge:Low
10
High
50
Unit
mg/dL
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880893
Page 198 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.f Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
24Initial Entry
5.f LNMT
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
10
High
50
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:48Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880894
Page 199 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Test:: Creatinine_
PX48
Result:: 0.85
Not Done::
Lab Normal Range
:Low
0.50
High
1.20
Unit
mg/dL
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880895
Page 200 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.g Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
0.85Initial Entry
5.g LNMT
Date Location User Value Reason
Mar-17-2021 10:39:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
0.50
High
1.20
Unit
mg/dLInitial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880896
Page 201 of 267
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 21-Aug-2020 02:51 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880897
Page 202 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sanatorio de la Providencia - Tu
cuman St. #1863 Buenos Aires C
ity.Initial Entry
3. Collection Date:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:1
Test:: Hemoglobin
_PX1
Result:: 15.6Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880898
Page 203 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Not Done::
Lab Normal Rang
e:Low
13
High
16
Unit
g/dL
5.a Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15.6Initial Entry
5.a LNMT
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
13
High
16Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880899
Page 204 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unit
g/dL
5.b
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:2
Test:: Hematocrit_
PX2
Result:: 45
Not Done::
Lab Normal Range
:Low
40
High
50
Unit
%Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880900
Page 205 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314075 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.b Sponsor ID:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
45Initial Entry
5.b LNMT
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Low
40
High
50
Unit
%Initial Entry
5.c
Date Location User Value Reason
Mar-17-2021 10:48:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:3Initial Entry
090177e196ae2f0f\Final\Final On: 01-Apr-2021 03:32 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0880901
Page 206 of 267
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Mar/12/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Au
…[truncated]