125742 S1 M5 CRF c4591001 4444 44441873

Document text

Page 1 of 160
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005729
Page 2 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005730
Page 3 of 160
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Demography
1.Subject ID [44441873]
2.Birth Date: /1945
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005731
Page 4 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005732
Page 5 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005733
Page 6 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005734
Page 7 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Prostate cancer]
Start Date: Dec/3/2015
Ongoing: NO
End Date:
Feb/3/2016
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Arterial hypertension]
Start Date: Mar/1/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Mild intermittent asthma]
Start Date: Jan/3/2000
Ongoing: YES
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005735
Page 8 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Left nephrectomy]
Start Date: Oct/18/1999
Ongoing: NO
End Date:
Oct/18/1999
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Clear cell renal cell carcinoma]
Start Date: Oct/1/1999
Ongoing: NO
End Date:
Oct/30/1999
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005736
Page 9 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005737
Page 10 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [110.7]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [37.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005738
Page 11 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [265417]
3.Randomization Group: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005739
Page 12 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRVNYD]
5.bSample ID [BRVNYT]
5.cSample ID [BHXGDH]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005740
Page 13 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWBX8]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005741
Page 14 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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/25/2020 12:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005742
Page 15 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005743
Page 16 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005744
Page 17 of 160
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005745
Page 18 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKNZG3]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005746
Page 19 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: Oct/15/2020 12:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005747
Page 20 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005748
Page 21 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
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 [BP1PYT]
5.bSample ID [BNTRCF]
5.cSample ID [BNTR86]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005749
Page 22 of 160
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005750
Page 23 of 160
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005751
Page 24 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005752
Page 25 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005753
Page 26 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005754
Page 27 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005755
Page 28 of 160
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005756
Page 29 of 160
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005757
Page 30 of 160
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005758
Page 31 of 160
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005759
Page 32 of 160
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005760
Page 33 of 160
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005761
Page 34 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005762
Page 35 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005763
Page 36 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005764
Page 37 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005765
Page 38 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005766
Page 39 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Unplanned Assessments
1.Assessments
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005767
Page 40 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Gallstones (gallbl
adder stones) Dec/13/20
20 20:00 NO
End Date Time:
Jan/7/2021 16:00
 Repeating
Pages
 2.ADVERSE
EVENT 2  Acute pancreatiti
s Dec/16/20
20 12:00 NO
End Date Time:
Jan/7/2021 16:00
 Repeating
Pages
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005768
Page 41 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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)[Gallstones (gallbladder stones)]
4.Start Date Time: Dec/13/2020 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/7/2021 16:00
6.Toxicity Grade: 4
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005769
Page 42 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
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]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005770
Page 43 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
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[2020502346]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005771
Page 44 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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)[Acute pancreatitis]
4.Start Date Time: Dec/16/2020 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/7/2021 16:00
6.Toxicity Grade: 3
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005772
Page 45 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
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:
[gallstones]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005773
Page 46 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
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[2020502346]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005774
Page 47 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005775
Page 48 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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[ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005776
Page 49 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005777
Page 50 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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: //
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005778
Page 51 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005779
Page 52 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005780
Page 53 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005781
Page 54 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005782
Page 55 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005783
Page 56 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005784
Page 57 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005785
Page 58 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005786
Page 59 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005787
Page 60 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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?
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005788
Page 61 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005789
Page 62 of 160
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005790
Page 63 of 160
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005791
Page 64 of 160
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005792
Page 65 of 160
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005793
Page 66 of 160
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005794
Page 67 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005795
Page 68 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005796
Page 69 of 160
***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, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005797
Page 70 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005798
Page 71 of 160
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005799
Page 72 of 160
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005800
Page 73 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005801
Page 74 of 160
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005802
Page 75 of 160
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005803
Page 76 of 160
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
ItemDate User Comment
FormSep-25-2020 16:32:04 (UTC-03:00)
City of Buenos AiresMartina
DavalliNot Applicable
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005804
Page 77 of 160
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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 Feb-27-2021 10:52:54 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-18-2021 00:06:43 (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.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005805
Page 78 of 160
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
 N/A Feb-10-2021 16:12:25 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-05-2021 12:56:57 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-29-2021 14:54:41 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo
Perez Marc Approved Jan-22-2021 17:17:59 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005806
Page 79 of 160
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Affidavit:
By my dated signature below, I, GonzaloPerez, 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 Dec-18-2020 11:01:48 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-13-2020 10:29:39 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005807
Page 80 of 160
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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.
Alan
Colombo N/A Nov-12-2020 18:37:37 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 12:24:24 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005808
Page 81 of 160
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
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.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005809
Page 82 of 160
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-25-2020
16:31:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-25-2020
16:31:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005810
Page 83 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-25-2020
16:31:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/25/2020Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005811
Page 84 of 160
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020
10:55:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44441873Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020
10:53:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1945Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-25-2020
16:31:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020
16:31:43ACV0PFEINFP6000  Martina
DavalliData Entry:
HISPANIC OR LATInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005812
Page 85 of 160
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresINO(A) OR OF SPA
NISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-25-2020
16:31:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
WHITEInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005813
Page 86 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
16:31:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/25/2020Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005814
Page 87 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-25-2020
16:32:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020
16:32:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020
16:32:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005815
Page 88 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1.a
Date Location User Value Reason
Sep-25-2020
16:34:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Prostate
cancer
Start Date: Dec/3/20
15
Ongoing: NO
End Da
te:
Feb/3/
2016Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-25-2020
16:34:01
(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
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005816
Page 89 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-25-2020
16:34:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Prostate cancerInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-25-2020
16:34:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Dec/3/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-25-2020
16:34:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO
End Date:
Feb/3/2016Initial Entry
1.b
Date Location User Value Reason
Sep-25-2020
16:36:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Arterial h
ypertensio
nInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005817
Page 90 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Start Date
:Mar/1/20
00
Ongoing: YES
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005818
Page 91 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.b Line/MH Number:
Date Location User Value Reason
Sep-25-2020
16:36:18
(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
Sep-25-2020
16:36:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Arterial hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-25-2020
16:36:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Mar/1/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-25-2020
16:36:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005819
Page 92 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c
Date Location User Value Reason
Sep-25-2020
16:37:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Mild inter
mittent ast
hma
Start Date
:Jan/3/2000
Ongoing: YESInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005820
Page 93 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.c Line/MH Number:
Date Location User Value Reason
Sep-25-2020
16:37:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020
16:37:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Mild intermittent ast
hmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-25-2020
16:37:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/3/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-25-2020
16:37:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005821
Page 94 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.d
Date Location User Value Reason
Sep-25-2020
16:38:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical Hi
story Term
:Left nephr
ectomy
Start Date: Oct/18/19
99
Ongoing: NO
End Dat
e:
Oct/18
/1999Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005822
Page 95 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.d Line/MH Number:
Date Location User Value Reason
Sep-25-2020
16:38:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020
16:38:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Left nephrectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-25-2020
16:38:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Oct/18/1999Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-25-2020
16:38:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO
End Date:Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005823
Page 96 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct/18/1999
1.e
Date Location User Value Reason
Sep-25-2020
16:39:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:5
Medical
History
Term:Clear cell re
nal cell carci
noma
Start Da
te:Oct/1/1999
Ongoing
:NO
End Date:
Oct/30/19
99Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005824
Page 97 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
1.e Line/MH Number:
Date Location User Value Reason
Sep-25-2020
16:39:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020
16:39:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Clear cell renal cell c
arcinomaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-25-2020
16:39:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Oct/1/1999Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-25-2020
16:39:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO
End Date:Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005825
Page 98 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Oct/30/1999
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005826
Page 99 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-25-2020
16:40:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
The subject is NOT
known to be HIV P
OSITIVETranscription
Error
Sep-25-2020
16:40:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
The subject is kno
wn to be HIV POSI
TIVEInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005827
Page 100 of 160
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
110.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-25-2020 ACV0PFEINFP6000  Martina Data Entry: Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005828
Page 101 of 160
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
16:40:56
(UTC-03:00) City
of Buenos AiresDavalli 173.0
5. Unit:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.0Initial Entry
7.a
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:CInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005829
Page 102 of 160
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005830
Page 103 of 160
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Sep-25-2020
16:40:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005831
Page 104 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020
16:41:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-25-2020
16:41:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
265417Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005832
Page 105 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
16:41:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
16:41:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
18:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
16:41:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005833
Page 106 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-25-2020
16:41:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection
:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
18:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRVNY
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
18:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRVNYDInitial Entry
5.b
Date Location User Value Reason
Sep-25-2020
18:29:42ACV0PFEINFP6000  Alan Colombo Data Entry: Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005834
Page 107 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresSample I
D:BRVNY
T
5.b Sample ID
Date Location User Value Reason
Sep-25-2020
18:29:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BRVNYTInitial Entry
5.c
Date Location User Value Reason
Sep-27-2020
09:27:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
Sample I
D:BHXGD
HInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-27-2020
09:27:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Agustin
Morato
CabralData Entry:
BHXGDHInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005835
Page 108 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
16:41:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
16:41:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
16:46:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
16:41:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005836
Page 109 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Sep-25-2020
16:41:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection
:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
16:46:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWBX
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
16:46:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWBX8Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005837
Page 110 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020
16:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020
16:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020
16:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020
16:41:39ACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/25/2020 12:30Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005838
Page 111 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020
16:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020
16:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-25-2020
16:41:39
(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-25-2020
16:41:39ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005839
Page 112 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-25-2020
16:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005840
Page 113 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-25-2020
16:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005841
Page 114 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
17:24:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005842
Page 115 of 160
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020
17:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2.a
Date Location User Value Reason
Oct-15-2020
17:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-15-2020
17:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005843
Page 116 of 160
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
2.a Temperature:
Date Location User Value Reason
Oct-15-2020
17:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-15-2020
17:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-15-2020
17:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005844
Page 117 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
16:53:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
16:53:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
16:53:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
16:53:04
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005845
Page 118 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires are entered.
Please review
and correct as
appropriate.
Oct-15-2020
16:53:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collectio
n:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
16:53:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BKNZG
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
16:53:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BKNZG3Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005846
Page 119 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020
17:25:25ACV0PFEINFP6000  Data Entry:
Oct/15/2020 12:56Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005847
Page 120 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020
17:25:25ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005848
Page 121 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresCIFIED OBSERVATIO
N PERIOD
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-15-2020
17:25:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005849
Page 122 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020
19:39:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005850
Page 123 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020
18:37:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020
18:37:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020
18:37:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-12-2020
18:37:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005851
Page 124 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Please review
and correct as
appropriate.
Nov-12-2020
18:37:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collectio
n:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020
18:37:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BP1PY
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020
18:37:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1PYTInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020
19:02:48ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005852
Page 125 of 160
***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: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos AiresSample ID
:BNTRC
F
5.b Sample ID
Date Location User Value Reason
Nov-12-2020
19:02:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTRCFInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020
19:13:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BNTR8
6Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020
19:13:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BNTR86Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1005853
Page 126 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005854
Page 127 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005855
Page 128 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021
00:55:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed moving to
correct
location
Jan-13-2021
00:55:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical Event
term of
Choledochal
Syndrome
codes to 'cyst'
and SAE
narrative
reports gall
bladder stones.
Please review
event term and
update if
appropriate for
both AE and
SAE.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005856
Page 129 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021
20:48:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Feb-11-2021
10:15:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Gallstones (gallbla
dder stones)New
Information
Feb-10-2021
16:49:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
GallstonesTranscription
Error
Feb-10-2021
16:12:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dBy request of
Safety, the
term is
changed from
SAE to
gallbladder
lithiasis. Start
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1005857
Page 130 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
date 13 Dec
2020 time
20:00 hs.
Update form
sent to sponsor
Feb-10-2021
16:12:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
gallbladder lithiasi
sBy request of
Safety, the
term is
changed from
SAE to
gallbladder
lithiasis. Start
date 13 Dec
2020 time
20:00 hs.
Update form
sent to sponsor
Jan-13-2021
00:55:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened Clinical Event
term of
Choledochal
Syndrome
codes to 'cyst'
and SAE
narrative
reports gall
bladder stones.
Please review
event term and
update if
appropriate for
both AE and
SAE.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005858
Page 131 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Dec-21-2020
15:31:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Clinical Please
consider a
more specific
event term;
current
Choledochal
Syndrome is
coding to
Choledochal
Cyst.
Dec-21-2020
13:18:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Clinical Thank
you for
extensive lab
data in SAE
report; please
update amylase
results with the
lab normal
range for that
test.
Dec-18-2020
11:01:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choledochal Syndr
omeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020
11:01:48ACV0PFEINFP6000  Data Entry:
Dec/13/2020 20:00Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1005859
Page 132 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
(UTC-03:00) City
of Buenos Aires
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-09-2021
09:50:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/7/2021 16:00New
Information
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1005860
Page 133 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
prevent above outcomes).
Date Location User Value Reason
Feb-25-2021
20:48:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Closed Response
satisfies query
Feb-10-2021
16:55:46
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Answere
dAt the request of
DM, Acute
Pancreatitis was
reported, which
was interpreted
as a
complication, in
a new report to
Pfizer Safety
associated with
case
2020502346.
Date and time of
onset of Acute
Pancreatitis
12/16/20 12:00
hs
Jan-13-2021
01:00:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Opened CLINICAL On
review of the
SAE report
(#2020502346),
an event of
acute
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005861
Page 134 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
pancreatitis was
reported. If this
complication
prolonged Hosp
or met other
serious criteria
including Med
Important,
please report as
a 2nd SAE event
term
Dec-31-2020
12:52:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Dec-31-2020
12:51:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Dec-28-2020
12:24:00
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
dIn SAE update
says "I clarify
that during
hospitalization
COVID test was
not performed".
In the same day
was sent 2
follow up forms,
this aclaration is
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005862
Page 135 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
in one of them.
Dec-25-2020
19:56:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answere
dBoth criteria are
listed on the
SAE Initial
Report Form
Dec-25-2020
13:22:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Reissue
d:OpenedClinical Thank
you; however
SAE update on
23Dec20 did not
include
information on
COVID testing
during
hospitalization
Dec-23-2020
13:57:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
dfollow-up SAE
form was sent
Dec-22-2020
08:05:18
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-21-2020
13:17:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005863
Page 136 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
SAE. Please
submit a
follow-up SAE
form
[#2020502346]
to document if
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date and
results.
Dec-21-2020
13:17:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened CLINICAL -
Serious criteria
are Hosp and
Medically
Important;
however, SAE
report criteria
for Serious has
Hosp. Please
review,
harmonize
reporting, and
update in the
appropriate
location.
Dec-18-2020
11:01:48
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teFor AE
Choledochal
Syndrome:
Response to "Is
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005864
Page 137 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Dec-18-2020
11:01:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated w
ith congenital an
omaly or birth d
efect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or signiInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005865
Page 138 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
ficant disability/
incapacity?
NO
Is this serious ev
ent life threateni
ng?
NO
Other medically
important seriou
s 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.
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to studInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005866
Page 139 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
of Buenos Aires y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021
00:51:40
(UTC-03:00)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005867
Page 140 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Aires
Dec-28-2020
16:41:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answer
edOn 28 DEC
2020, a
follow-up form
for the serious
adverse event is
sent
Dec-27-2020
12:37:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Reissue
d:OpenedCLINICAL
Thank you;
please submit
this information
to the SAE
(#2020502346)
in a safety
followup FAX
Dec-25-2020
20:01:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answer
edOn DEC 20,
2020, the
volunteer
underwent
laparoscopic
cholecystectomy
plus transcystic
instrumentation
of the bile duct
with stone
removal
Dec-25-2020
20:01:17
(UTC-03:00)ACV0PFEINFP6000  Data Entry:
YESOn DEC 20,
2020, the
volunteer
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005868
Page 141 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
City of Buenos
Airesunderwent
laparoscopic
cholecystectomy
plus transcystic
instrumentation
of the bile duct
with stone
removal
Dec-21-2020
13:16:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Clinical Please
clarify if a
procedure was
performed for
the event of
Choledochal
syndrome,
including date. If
yes; please
update Non-drug
Treatment given
& submit
information to
SAE.
Dec-18-2020
11:01:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005869
Page 142 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Jan-09-2021
09:50:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Close
dClose Auto Query
Jan-09-2021
09:50:22
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERED/
RESOLVEDNew Information
Jan-09-2021
09:50:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opene
dFor AE Choledochal
Syndrome: Response
to "What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Dec-23-2020
13:58:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RECOVERIN
G/RESOLVIN
GNew Information
Dec-18-2020
11:01:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RECOVE
RED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005870
Page 143 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Date Location User Value Reason
Dec-18-2020
11:01:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-22-2020
08:05:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2020502346Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005871
Page 144 of 160
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Category:
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Acute pancreatitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005872
Page 145 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/16/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/7/2021 16:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005873
Page 146 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Mar-01-2021
14:37:21
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Feb-27-2021
10:52:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answere
dTranscription
Error
Feb-27-2021
10:52:54
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wit
h congenital ano
maly or birth def
ect?
NO
Did this serious e
vent result in dea
th?
NO
Did this serious e
vent require or pr
olong hospitaliza
tion?
YESTranscription
Error
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005874
Page 147 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Did this serious e
vent result in per
sistent or signific
ant disability/inc
apacity?
NO
Is this serious ev
ent life threatenin
g?
NO
Other medically i
mportant serious
event
YES
Feb-26-2021
13:17:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened CLINICAL
Serious criteria
for event
Pancreatitis is
HOSP;
however, SAE
report has
criteria HOSP
and Med
Important.
Please review,
harmonize
reporting, and
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005875
Page 148 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
update where
applicable
Feb-25-2021
20:51:50
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Candidat
eCLINICAL
Serious criteria
for event
Pancreatitis is
HOSP;
however, SAE
report has
criteria HOSP
and Med
Important.
Please review,
harmonize
reporting, and
update where
applicable
Feb-16-2021
02:15:07
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-15-2021
18:29:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eFor AE Acute
pancreatitis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005876
Page 149 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
blank.
Feb-15-2021
18:29:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious ev
ent associated wit
h congenital ano
maly or birth def
ect?
NO
Did this serious e
vent result in dea
th?
NO
Did this serious e
vent require or pr
olong hospitaliza
tion?
YES
Did this serious e
vent result in per
sistent or signific
ant disability/inc
apacity?
NO
Is this serious evInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005877
Page 150 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
ent life threatenin
g?
NO
Other medically i
mportant serious
event
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.
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005878
Page 151 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
gallstones
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005879
Page 152 of 160
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-15-2021
18:29:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-16-2021
02:15:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2020502346Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005880
Page 153 of 160
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020
19:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020
19:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020
19:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005881
Page 154 of 160
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021
14:54:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005882
Page 155 of 160
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-29-2021
14:54:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-29-2021
14:54:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-29-2021
14:54:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to h
ave received onl
y placebo at VacInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005883
Page 156 of 160
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
cination 1/2
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-1005884
Page 157 of 160
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-29-2021
14:54:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021
14:54:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005885
Page 158 of 160
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020
19:39:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-25-2020
16:41:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-25-2020
16:32:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-16-2021
02:16:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Cl
osedResponse satisfies query
Feb-15-2021
18:30:07
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Query 1: An
sweredSAE was uploaded. Thank
you.
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005886
Page 159 of 160
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Aires
Feb-15-2021
07:39:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Op
enedSAE
RECON:AER#2020502346
acute pancreatitis(onset
date:16Dec2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Nov-12-2020
19:39:36
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry
:
Nov/12/202
0Initial Entry
Sep-25-2020
16:41:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry
:
Sep/25/2020Initial Entry
Sep-25-2020
16:32:14
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry
:
Sep/25/2020Initial Entry
090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1005887
Page 160 of 160
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 4444 Site Name: (4444) Hospital Militar Central Cirujano
Mayor Dr Cosme Argerich
Subject No: 44441873 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 17:38
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
12:24:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
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090177e196ae2e9c\Final\Final On: 01-Apr-2021 03:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1005888