125742 S1 M5 CRF c4591001 1231 12314894

Document text

Page 1 of 183
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886074
Page 2 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886075
Page 3 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [12314894]
2.Birth Date: /1994
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886076
Page 4 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886077
Page 5 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886078
Page 6 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886079
Page 7 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Pneumonia]
Start Date: Jun/1/2005
Ongoing: NO
End Date:
Jun/15/2005
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bronchial asthma]
Start Date: May/1/2005
Ongoing: NO
End Date:
Jun/1/2006
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886080
Page 8 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [78.9]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [28.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886081
Page 9 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/28/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886082
Page 10 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [72865]
3.Randomization Group: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886083
Page 11 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPWW4P]
5.bSample ID [BPWW4R]
5.cSample ID [BPWW4S]
5.dSample ID [BJ4B8D]
5.eSample ID [BJ4B8F]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886084
Page 12 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPTDSS]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886085
Page 13 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 17:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886086
Page 14 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886087
Page 15 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886088
Page 16 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886089
Page 17 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886090
Page 18 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2BLF]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886091
Page 19 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 18:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886092
Page 20 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886093
Page 21 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BLBH1K]
5.bSample ID [BLBH0X]
5.cSample ID [BPWDHK]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886094
Page 22 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886095
Page 23 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886096
Page 24 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886097
Page 25 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886098
Page 26 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886099
Page 27 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886100
Page 28 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886101
Page 29 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886102
Page 30 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886103
Page 31 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886104
Page 32 of 183
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886105
Page 33 of 183
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886106
Page 34 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886107
Page 35 of 183
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB
- New Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886108
Page 36 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  right retroatrial i
nflammation Sep/21/202
0 08:00 NO
End Date Time:
Sep/21/2020 20:0
0
 Repeating
Pages
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886109
Page 37 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[right retroatrial inflammation]
4.Start Date Time: Sep/21/2020 08:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/21/2020 20:00
6.Toxicity Grade: 1
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886110
Page 38 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unkonwn]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886111
Page 39 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886112
Page 40 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886113
Page 41 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886114
Page 42 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886115
Page 43 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886116
Page 44 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886117
Page 45 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886118
Page 46 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886119
Page 47 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886120
Page 48 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886121
Page 49 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886122
Page 50 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886123
Page 51 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886124
Page 52 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886125
Page 53 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886126
Page 54 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886127
Page 55 of 183
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886128
Page 56 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886129
Page 57 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/5/2021
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886130
Page 58 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNTRT7]
5.bSample ID [BHXH11]
5.cSample ID [BPTH4F]
5.dSample ID [BNTRSG]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886131
Page 59 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTH4F]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886132
Page 60 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886133
Page 61 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMD8Y]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886134
Page 62 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886135
Page 63 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1LZ3]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886136
Page 64 of 183
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886137
Page 65 of 183
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886138
Page 66 of 183
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/5/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886139
Page 67 of 183
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886140
Page 68 of 183
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886141
Page 69 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/9/2021
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886142
Page 70 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/9/2021
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886143
Page 71 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886144
Page 72 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Mar/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886145
Page 73 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/9/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886146
Page 74 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRYXBD]
5.bSample ID [BR1PKP]
5.cSample ID [BRYXB6]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886147
Page 75 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR22V1]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886148
Page 76 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/9/2021 17:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886149
Page 77 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886150
Page 78 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886151
Page 79 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886152
Page 80 of 183
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886153
Page 81 of 183
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886154
Page 82 of 183
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886155
Page 83 of 183
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886156
Page 84 of 183
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886157
Page 85 of 183
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886158
Page 86 of 183
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886159
Page 87 of 183
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886160
Page 88 of 183
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886161
Page 89 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886162
Page 90 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886163
Page 91 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormAug-28-2020 18:35:00
(UTC-03:00) City of Buenos AiresNot Applicable
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886164
Page 92 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormMar-10-2021 11:13:43 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886165
Page 93 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-08-2021 11:39:15 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Carola
Baldoni Approved Mar-06-2021 16:08:48 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, CarolaBaldoni, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-06-2021 10:54:37 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886166
Page 94 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
N/A
 Approved Feb-18-2021 17:11:44 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-18-2021 17:10:02 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-09-2021 11:25:07 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886167
Page 95 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-05-2021 14:56:01 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 21:33:58 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886168
Page 96 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886169
Page 97 of 183
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020
18:34:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020
18:34:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886170
Page 98 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020
18:34:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/28/2020Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886171
Page 99 of 183
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020
16:30:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314894Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020
16:30:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1994Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020
18:34:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020
18:34:45ACV0PFEINFP6000  Data Entry:
HISPANIC OR LAInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886172
Page 100 of 183
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos AiresTINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020
18:34:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886173
Page 101 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020
18:34:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886174
Page 102 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020
18:35:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020
18:35:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020
18:35:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886175
Page 103 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020
18:35:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Pneumon
ia
Start Date: Jun/1/20
05
Ongoing: NO
End Da
te:
Jun/1
5/200
5Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020
18:35:44
(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
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886176
Page 104 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-28-2020
18:35:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PneumoniaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020
18:35:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/1/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020
18:35:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/15/2005Initial Entry
1.b
Date Location User Value Reason
Aug-28-2020
18:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical Hi
story Term
:Bronchial
asthmaInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886177
Page 105 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Start Date: May/1/20
05
Ongoing: NO
End Dat
e:
Jun/1/
2006
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886178
Page 106 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020
18:36:06
(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
Aug-28-2020
18:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bronchial asthmaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020
18:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
May/1/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020
18:36:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886179
Page 107 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Jun/1/2006
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886180
Page 108 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
78.9Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886181
Page 109 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
18:36:29
(UTC-03:00) City
of Buenos Aires167.0
5. Unit:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.3Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record I
dentifier:
:1
Temperat
ure:37.0
Temperat
ure Unit:CInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886182
Page 110 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Temperat
ure Locat
ion::ORAL
CAVI
TY
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886183
Page 111 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-28-2020
18:36:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886184
Page 112 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886185
Page 113 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
18:36:39
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886186
Page 114 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020
18:36:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886187
Page 115 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020
18:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020
18:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
72865Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886188
Page 116 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
18:37:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
18:37:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020
15:40:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
18:37:09
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886189
Page 117 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires are entered.
Please review
and correct as
appropriate.
Aug-28-2020
18:37:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020
15:40:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample I
D:BPWW
4PInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-29-2020
15:40:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPWW4PInitial Entry
5.b
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886190
Page 118 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-29-2020
15:40:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample I
D:BPWW4
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-29-2020
15:40:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPWW4RInitial Entry
5.c
Date Location User Value Reason
Aug-29-2020
15:41:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample I
D:BPWW
4SInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-29-2020
15:41:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPWW4SInitial Entry
5.d
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886191
Page 119 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Aug-29-2020
16:03:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I
D:BJ4B8
DInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-29-2020
16:03:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ4B8DInitial Entry
5.e
Date Location User Value Reason
Aug-29-2020
16:03:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID
:BJ4B8
FInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-29-2020
16:03:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BJ4B8FInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886192
Page 120 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
18:37:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
18:37:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020
10:37:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
18:37:15
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
Yes, however
no barcodes
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886193
Page 121 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aires are entered.
Please review
and correct as
appropriate.
Aug-28-2020
18:37:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collecti
on:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020
10:37:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPTDS
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-30-2020
10:37:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPTDSSInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886194
Page 122 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020
18:37:28ACV0PFEINFP6000  Data Entry:
Aug/28/2020 17:1Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886195
Page 123 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires5
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020
18:37:28ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886196
Page 124 of 183
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(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
Aug-28-2020
18:37:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886197
Page 125 of 183
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020
18:38:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUB
JECTInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886198
Page 126 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-19-2020
08:34:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886199
Page 127 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-19-2020
08:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-19-2020
08:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.0
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-19-2020
08:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886200
Page 128 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
2.a Temperature:
Date Location User Value Reason
Sep-19-2020
08:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-19-2020
08:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-19-2020
08:35:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886201
Page 129 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-19-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886202
Page 130 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
08:35:22
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886203
Page 131 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-19-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886204
Page 132 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
08:35:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
08:35:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
08:35:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886205
Page 133 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Sep-17-2020
08:35:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BP2BL
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
08:35:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP2BLFInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886206
Page 134 of 183
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-19-2020
08:35:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-19-2020
08:35:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-19-2020
08:35:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-19-2020
08:35:42ACV0PFEINFP6000  Data Entry:
Sep/16/2020 18:55Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886207
Page 135 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-19-2020
08:35:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-19-2020
08:35:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-19-2020
08:35:42
(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-19-2020
08:35:42ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886208
Page 136 of 183
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(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-19-2020
08:35:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886209
Page 137 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
15:45:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886210
Page 138 of 183
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
15:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
15:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
16:14:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
15:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886211
Page 139 of 183
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Oct-19-2020
15:45:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
16:14:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLBH1
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
16:14:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLBH1KInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020
17:08:02
(UTC-03:00) CityACV0PFEINFP6000  Alan Colombo Data Entry:
Sample I BLBH0Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886212
Page 140 of 183
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires D: X
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
17:08:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBH0XInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020
18:03:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWDH
KInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
18:03:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWDHKInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0886213
Page 141 of 183
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020
15:46:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
15:46:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
15:46:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886214
Page 142 of 183
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886215
Page 143 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
right retroatrial inflam
mationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-09-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0886216
Page 144 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
13:39:53
(UTC-03:00) City
of Buenos AiresSep/21/2020 08:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/21/2020 20:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886217
Page 145 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this e
vent is due to:
OTHER
If Other, specify:
UnkonwnInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886218
Page 146 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-09-2020
13:39:53
(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?
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886219
Page 147 of 183
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Oct-09-2020
13:39:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886220
Page 148 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021
14:56:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886221
Page 149 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-05-2021
14:56:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/5/2021Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886222
Page 150 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021
14:56:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021
14:56:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-06-2021
12:20:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-05-2021
14:56:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886223
Page 151 of 183
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Feb-05-2021
14:56:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/5/2021Initial Entry
5.a
Date Location User Value Reason
Feb-06-2021
12:20:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTRT
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-06-2021
12:20:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTRT7Initial Entry
5.b
Date Location User Value Reason
Feb-08-2021
10:25:15
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I BHXH1Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886224
Page 152 of 183
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires D: 1
5.b Sample ID
Date Location User Value Reason
Feb-08-2021
10:25:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BHXH11Initial Entry
5.c
Date Location User Value Reason
Feb-08-2021
12:21:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTH
4FTranscription
Error
(DELETED)
Feb-08-2021
11:50:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTH
4FInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886225
Page 153 of 183
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
5.c Sample ID
Date Location User Value Reason
Feb-08-2021
12:21:47
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BPTH4FTranscription
Error
(DELETED)
Feb-08-2021
11:50:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BPTH4FInitial Entry
5.d
Date Location User Value Reason
Feb-08-2021
14:56:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BNTRS
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-08-2021
14:56:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNTRSGInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886226
Page 154 of 183
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021
17:25:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021
17:25:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-08-2021
12:38:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-08-2021
08:59:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0886227
Page 155 of 183
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Feb-05-2021
17:25:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-05-2021
17:25:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/5/2021Initial Entry
5.a
Date Location User Value Reason
Feb-08-2021
12:38:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPTH4
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021
12:38:12
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
BPTH4FInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886228
Page 156 of 183
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886229
Page 157 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021
17:10:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-18-2021
17:10:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK2Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886230
Page 158 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021
17:10:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021
17:10:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-18-2021
17:10:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-18-2021
17:10:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886231
Page 159 of 183
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/17/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Feb-18-2021
17:10:23
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-18-2021
17:10:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRMD8
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-18-2021
17:10:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRMD8YInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886232
Page 160 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
11:39:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Mar-08-2021
11:39:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SSWAB_WEEK4Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886233
Page 161 of 183
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021
11:39:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021
11:39:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021
11:41:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
11:39:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886234
Page 162 of 183
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Mar-08-2021
11:39:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Mar/5/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021
11:41:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR1LZ
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021
11:41:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR1LZ3Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886235
Page 163 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-06-2021
10:54:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886236
Page 164 of 183
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-06-2021
10:55:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Delete
dClose Auto
Query
Mar-06-2021
10:54:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Mar-06-2021
10:54:49
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participant is wi
lling to return fo
r Vaccination 3
Participant is:
eligible per o
ther protocol
allowance(s)Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886237
Page 165 of 183
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
and confirme
d to have rec
eived only pl
acebo at Vac
cination 1/2
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886238
Page 166 of 183
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-06-2021
10:55:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-06-2021
10:55:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBI
LITY FOR ADDI
TIONAL VACCIN
ATIONInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886239
Page 167 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
11:13:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/9/2021Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886240
Page 168 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-10-2021
11:13:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Mar/9/2021Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886241
Page 169 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-10-2021
11:14:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/9/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021
11:14:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Mar-10-2021
11:14:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886242
Page 170 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/9/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Mar-10-2021 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886243
Page 171 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
11:14:13
(UTC-03:00) City
of Buenos Aires(autocalc) STUDY SITE
5. Specimen Type:
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886244
Page 172 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Mar-10-2021
11:14:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886245
Page 173 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021
11:14:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021
11:14:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021
11:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
11:14:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886246
Page 174 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Mar-10-2021
11:14:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/9/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021
11:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRYXB
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021
11:18:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYXBDInitial Entry
5.b
Date Location User Value Reason
Mar-10-2021
12:33:53
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sample I BR1PKInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886247
Page 175 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
of Buenos Aires D: P
5.b Sample ID
Date Location User Value Reason
Mar-10-2021
12:33:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR1PKPInitial Entry
5.c
Date Location User Value Reason
Mar-10-2021
12:34:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRYX
B6Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-10-2021
12:34:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRYXB6Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886248
Page 176 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021
11:14:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021
11:14:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021
12:23:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-10-2021
11:14:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886249
Page 177 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Please review
and correct as
appropriate.
Mar-10-2021
11:14:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/9/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021
12:23:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BR22V
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021
12:23:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR22V1Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886250
Page 178 of 183
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-10-2021
11:15:01ACV0PFEINFP6000  Data Entry:
Mar/9/2021 17:41Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886251
Page 179 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-10-2021
11:15:01ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886252
Page 180 of 183
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-03:00) City
of Buenos Aires
9. Unit:
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Mar-10-2021
11:15:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0886253
Page 181 of 183
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-19-2020
15:46:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020
18:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-28-2020
18:35:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-19-2020
15:46:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/19/2020Initial Entry
Aug-28-2020
18:36:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886254
Page 182 of 183
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Aug-28-2020
18:35:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0886255
Page 183 of 183
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12314894 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020
21:33:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196d6f285\Final\Final On: 22-Apr-2021 02:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0886256