125742 S1 M5 CRF c4591001 1231 12311379

Document text

Page 1 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861154
Page 2 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/15/2020
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861155
Page 3 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311379]
2.Birth Date: /1948
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861156
Page 4 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861157
Page 5 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861158
Page 6 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861159
Page 7 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861160
Page 8 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861161
Page 9 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861162
Page 10 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861163
Page 11 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861164
Page 12 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[arterial hypertension]
Start Date: Jan/1/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[PSA elevation]
Start Date: Aug/12/2018
Ongoing: YES
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861165
Page 13 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/15/2020
2.Weight: [91.6]
3.Unit: kg
4.Height: [174.0]
5.Unit: cm
6.Body Mass Index: [30.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861166
Page 14 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/15/2020
2.Randomization Number: [229565]
3.Randomization Group: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861167
Page 15 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLCVNV]
5.bSample ID [BLCVNT]
5.cSample ID [BM83XC]
5.dSample ID [BM83XB]
5.eSample ID [BM840B]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861168
Page 16 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM8449]
5.bSample ID [BM83XC ]
5.cSample ID [BM83XB ]
5.dSample ID [BM840B]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861169
Page 17 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/15/2020 15:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861170
Page 18 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861171
Page 19 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861172
Page 20 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861173
Page 21 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861174
Page 22 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861175
Page 23 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861176
Page 24 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1TM8]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861177
Page 25 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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/7/2020 18:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861178
Page 26 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861179
Page 27 of 227
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861180
Page 28 of 227
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861181
Page 29 of 227
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861182
Page 30 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNVB26]
5.bSample ID [BNV331]
5.cSample ID [BPW759]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861183
Page 31 of 227
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861184
Page 32 of 227
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861185
Page 33 of 227
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861186
Page 34 of 227
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861187
Page 35 of 227
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861188
Page 36 of 227
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861189
Page 37 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861190
Page 38 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861191
Page 39 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861192
Page 40 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861193
Page 41 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861194
Page 42 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861195
Page 43 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861196
Page 44 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861197
Page 45 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861198
Page 46 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861199
Page 47 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861200
Page 48 of 227
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: PROTOCOL DEVIATION
4.Specify Status: [The volunteer was given a vaccine not related to the study]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861201
Page 49 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861202
Page 50 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861203
Page 51 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861204
Page 52 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861205
Page 53 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861206
Page 54 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861207
Page 55 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861208
Page 56 of 227
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861209
Page 57 of 227
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861210
Page 58 of 227
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861211
Page 59 of 227
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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 [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861212
Page 60 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861213
Page 61 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR
otherwise not eligible
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861214
Page 62 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Prostate adeno
carcinoma. Nov/20/202
0 12:00 YES  Repeating
Pages
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861215
Page 63 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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)[Prostate adenocarcinoma.]
4.Start Date Time: Nov/20/2020 12:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861216
Page 64 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861217
Page 65 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021028480]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861218
Page 66 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861219
Page 67 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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[ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861220
Page 68 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Def
ined Identifi
erCategory fo
r Medicatio
nConcomitant Med
ications Pre-speci
fiedName of Medicati
onStart
DateForm Insta
nce
 1.1  VACCINAT
IONS NO  Gam-COVID-Vac (
trade name Sputnik
V). Feb/1
8/202
1 Repeating
Pages
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861221
Page 69 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Gam-COVID-Vac (trade name Sputnik V).]
5.Date: Feb/18/2021
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861222
Page 70 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861223
Page 71 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861224
Page 72 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861225
Page 73 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861226
Page 74 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861227
Page 75 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861228
Page 76 of 227
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861229
Page 77 of 227
***Confidential***
 
Header Text: C4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861230
Page 78 of 227
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861231
Page 79 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861232
Page 80 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861233
Page 81 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/24/2021
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861234
Page 82 of 227
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861235
Page 83 of 227
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-05-2021 14:07:24 (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.
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861236
Page 84 of 227
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-05-2021 14:07:24 (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-25-2021 12:33:26 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Gonzalo
Perez Marc Approved Feb-01-2021 12:36:37 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861237
Page 85 of 227
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, GonzaloPerez, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-29-2021 08:36:10 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-20-2021 20:34:35 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861238
Page 86 of 227
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-12-2021 15:51:39 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-22-2020 14:02:20 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861239
Page 87 of 227
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, FernandoPolack, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861240
Page 88 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-15-2020
18:29:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-15-2020
18:29:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861241
Page 89 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-15-2020
18:29:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Aug/15/2020Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861242
Page 90 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-15-2020
13:40:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311379Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-15-2020
13:40:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1948Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-15-2020
18:30:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-15-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861243
Page 91 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
18:30:03
(UTC-03:00) City
of Buenos AiresHISPANIC OR LA
TINO(A) OR OF S
PANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-15-2020
18:30:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861244
Page 92 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-15-2020
18:30:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861245
Page 93 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber
:1
Cri
teri
on
Des
crip
tion
:Male or fema
le participant
s between th
e ages of 18
and 55 years,
inclusive, 65
and 85 years,
inclusive, or
18 and 85 ye
ars, inclusive
, at randomiz
ation (depen
dent upon stu
dy stage)
Cri
teri
on
met
?:YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861246
Page 94 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Cri
teri
on I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female par
ticipants between t
he ages of 18 and 5
5 years, inclusive,
65 and 85 years, in
clusive, or 18 and
85 years, inclusive,
at randomization (Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861247
Page 95 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
dependent upon st
udy stage)
1.a Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:2Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861248
Page 96 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n D
escr
ipti
on:Participants
who are willi
ng and able t
o comply wit
h all schedul
ed visits, vac
cination plan
, laboratory t
ests, lifestyle
consideratio
ns, and other
study proced
ures
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN02A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861249
Page 97 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who ar
e willing and able t
o comply with all s
cheduled visits, va
ccination plan, lab
oratory tests, lifest
yle considerations,
and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861250
Page 98 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:3
Crit
erio
n D
escr
ipti
on:Healthy parti
cipants who
are determin
ed by medic
al history, ph
ysical exami
nation, and c
linical judgm
ent of the inv
estigator to b
e eligible for
inclusion in t
he studyInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861251
Page 99 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN03A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861252
Page 100 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participant
s who are determin
ed by medical hist
ory, physical exam
ination, and clinica
l judgment of the i
nvestigator to be el
igible for inclusion
in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861253
Page 101 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:4
Crit
erio
n D
escr
ipti
on:Capable of g
iving person
al signed inf
ormed conse
nt, which inc
ludes compli
ance with th
e requiremen
ts and restric
tions listed i
n the ICD an
d in this prot
ocolInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861254
Page 102 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN04A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861255
Page 103 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving
personal signed inf
ormed consent, wh
ich includes compl
iance with the requ
irements and restri
ctions listed in the
ICD and in this pro
tocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861256
Page 104 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mb
er:1Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861257
Page 105 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n D
escr
ipti
on:Other medic
al or psychia
tric conditio
n incl. recent
(within past
year) or activ
e suicidal ide
ation/behavi
or/lab abnor
mality that m
ay increase t
he risk of stu
dy participati
on
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861258
Page 106 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or p
sychiatric conditio
n incl. recent (with
in past year) or acti
ve suicidal ideatio
n/behavior/lab abn
ormality that may i
ncrease the risk of
study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861259
Page 107 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:2
Crit
erio
n De
scrip
tion:Known infe
ction with h
uman immu
nodeficienc
y virus (HI
V), hepatitis
C virus (HC
V), or hepat
itis B virus (
HBV)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861260
Page 108 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX02A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861261
Page 109 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection w
ith human immuno
deficiency virus (H
IV), hepatitis C vir
us (HCV), or hepat
itis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861262
Page 110 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mbe
r:3
Crit
erio
n D
escr
ipti
on:History of se
vere adverse
reaction asso
ciated with a
vaccine and/
or severe all
ergic reactio
n (eg, anaph
ylaxis) to an
y component
of the study i
ntervention(
s)Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861263
Page 111 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX03A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861264
Page 112 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe a
dverse reaction ass
ociated with a vacc
ine and/or severe a
llergic reaction (eg
, anaphylaxis) to a
ny component of t
he study interventi
on(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861265
Page 113 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:4
Criteri
on Des
criptio
n:Receipt o
f medicati
ons inten
ded to pre
vent COV
ID-19
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX04A00Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861266
Page 114 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861267
Page 115 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.e
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:8
Crit
erio
n D
escr
ipti
on:Immunocom
promised in
dividuals wit
h known or s
uspected im
munodeficie
ncy, as deter
mined by his
tory and/or l
aboratory/ph
ysical exami
nation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861268
Page 116 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX08A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861269
Page 117 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromi
sed individuals wit
h known or suspect
ed immunodeficien
cy, as determined b
y history and/or la
boratory/physical e
xaminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861270
Page 118 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:10
Crit
erio
n D
escr
ipti
on:Bleeding dia
thesis or con
dition associ
ated with pr
olonged blee
ding that wo
uld, in the o
pinion of the
investigator,
contraindicat
e intramuscu
lar injectionInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861271
Page 119 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX10A00
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861272
Page 120 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis
or condition associ
ated with prolonge
d bleeding that wo
uld, in the opinion
of the investigator,
contraindicate intra
muscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861273
Page 121 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:11
Criteri
on Desc
ription:Women
who are
pregnant
or breast
feeding
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX11A0
0Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861274
Page 122 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pr
egnant or breastfee
dingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861275
Page 123 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.h
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:12
Criteri
on Des
criptio
n:Previous
vaccinati
on with a
ny coron
avirus va
ccine
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX12A0
0Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861276
Page 124 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccinati
on with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861277
Page 125 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.i
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:13
Crite
rion
Desc
ripti
on:Subjects wh
o receive i
mmunosup
pressive the
rapy, such a
s cytotoxic
agents or sy
stemic corti
costeroids
Crite
rion
met?
:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861278
Page 126 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
ID: (
For
Pfize
r use
only)
:EX13A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861279
Page 127 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who recei
ve immunosuppres
sive therapy, such
as cytotoxic agents
or systemic cortico
steroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861280
Page 128 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:15
Crit
erio
n D
escr
ipti
on:Receipt of bl
ood/plasma
products or i
mmunoglob
ulin, from 6
0 days befor
e study inter
vention adm
inistration or
planned rece
ipt througho
ut the study
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861281
Page 129 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX14A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861282
Page 130 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/pl
asma products or i
mmunoglobulin, fr
om 60 days before
study intervention
administration or p
lanned receipt thro
ughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861283
Page 131 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861284
Page 132 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:16
Crit
erio
n De
scri
ptio
n:Participatio
n in other st
udies involv
ing study in
tervention
within 28 d
ays prior to
study entry
and/or durin
g study part
icipation
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861285
Page 133 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX15A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861286
Page 134 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Participation in ot
her studies involvi
ng study interventi
on within 28 days
prior to study entr
y and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861287
Page 135 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:17
Crite
rion
Desc
ripti
on:Previous p
articipation
in other stu
dies involv
ing study i
ntervention
containing
lipid nanop
articles
Crite
rion
met?
:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861288
Page 136 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
ID: (
For
Pfize
r use
only)
:EX16A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861289
Page 137 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Previous participat
ion in other studie
s involving study i
ntervention contai
ning lipid nanopar
ticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861290
Page 138 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mb
er:22Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861291
Page 139 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Cri
teri
on
Des
crip
tion
:Investigator
site staff or
Pfizer emplo
yees directly
involved in t
he conduct o
f the study, s
ite staff othe
rwise superv
ised by the i
nvestigator,
and their res
pective fami
ly members
Cri
teri
on
met
?:NO
Cri
teri
on I
D: (
For
Pfiz
er u
se o
nly)
:EX21A01
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861292
Page 140 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Investigator site st
aff or Pfizer emplo
yees directly invol
ved in the conduct
of the study, site st
aff otherwise supe
rvised by the inves
tigator, and their r
espective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861293
Page 141 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Aires
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-15-2020
18:30:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861294
Page 142 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-15-2020
18:30:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-15-2020
18:30:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-15-2020
18:30:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861295
Page 143 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-15-2020
21:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:arterial h
ypertensi
on
Start Date: Jan/1/200
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-15-2020
21:07:36
(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
Aug-15-2020
21:07:36
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
arterial hypertensionInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861296
Page 144 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
1.a Start Date:
Date Location User Value Reason
Aug-15-2020
21:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/1/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-15-2020
21:07:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-17-2021
18:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:PSA ele
vation
Start Date: Aug/12/
2018
Ongoing: YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861297
Page 145 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Line/MH Number:
Date Location User Value Reason
Jan-17-2021
18:17:28
(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
Jan-17-2021
18:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PSA elevationInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-17-2021
18:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/12/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-17-2021
18:17:28
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861298
Page 146 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861299
Page 147 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
91.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861300
Page 148 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
174.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.3Initial Entry
7.a
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:37.0Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861301
Page 149 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Temperatur
e Unit:C
Temperatur
e Location:
:ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861302
Page 150 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.a Temperature Location:
Date Location User Value Reason
Aug-15-2020
21:09:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861303
Page 151 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-15-2020
21:09:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-15-2020
21:09:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
229565Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861304
Page 152 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-15-2020
21:09:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-15-2020
21:09:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-16-2020
11:34:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-15-2020
21:09:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861305
Page 153 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Aug-15-2020
21:09:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-16-2020
11:34:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCVN
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-16-2020
11:34:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVNVInitial Entry
5.b
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861306
Page 154 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
11:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCVN
TInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-16-2020
11:34:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVNTInitial Entry
5.c
Date Location User Value Reason
Aug-16-2020
12:59:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BM83X
CInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-16-2020
12:59:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83XCInitial Entry
5.d
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861307
Page 155 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020
12:59:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BM83X
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-16-2020
12:59:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83XBInitial Entry
5.e
Date Location User Value Reason
Aug-16-2020
12:59:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BM840
BInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-16-2020
12:59:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM840BInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861308
Page 156 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-15-2020
21:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-15-2020
21:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-16-2020
12:58:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto
Query
Aug-16-2020
12:58:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened There are more
than 1 barcode
present for
sample
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861309
Page 157 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
collection.
Please review
and correct as
appropriate.
Aug-16-2020
12:58:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto
Query
Aug-16-2020
12:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened There are more
than 1 barcode
present for
sample
collection.
Please review
and correct as
appropriate.
Aug-16-2020
12:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Aug-16-2020
12:57:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened There are more
than 1 barcode
present for
sample
collection.
Please review
and correct as
appropriate.
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861310
Page 158 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
10:13:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-15-2020
21:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-15-2020
21:10:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-16-2020
10:13:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM84
49Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861311
Page 159 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020
10:13:43
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BM8449Initial Entry
5.b
Date Location User Value Reason
Aug-16-2020
12:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83X
CTranscription
Error
(DELETED)
Aug-16-2020
12:57:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83X
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-16-2020
12:58:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83XCTranscription
Error
(DELETED)
Aug-16-2020
12:57:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83XCInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861312
Page 160 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c
Date Location User Value Reason
Aug-16-2020
12:58:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83X
BTranscription
Error
(DELETED)
Aug-16-2020
12:57:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83X
BInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-16-2020
12:58:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83XBTranscription
Error
(DELETED)
Aug-16-2020
12:57:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83XBInitial Entry
5.d
Date Location User Value Reason
Aug-16-2020
12:58:52ACV0PFEINFP6000  Data Entry:
Sample I BM840Transcription
Error
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861313
Page 161 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City
of Buenos AiresD: B (DELETED)
Aug-16-2020
12:57:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM840
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-16-2020
12:58:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM840BTranscription
Error
(DELETED)
Aug-16-2020
12:57:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM840BInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861314
Page 162 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-15-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861315
Page 163 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
21:10:36
(UTC-03:00) City
of Buenos AiresAug/15/2020 15:35
5. Anatomical Location:
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861316
Page 164 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-15-2020
21:10:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861317
Page 165 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-15-2020
21:10:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGENI
CITY E-DIARY COL
LECTED FOR THIS
SUBJECTInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861318
Page 166 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020
19:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/7/2020Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861319
Page 167 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
2.a Symptom:
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861320
Page 168 of 227
***Confidential***
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861321
Page 169 of 227
***Confidential***
2.b Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: HE
A
D
AC
HE
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861322
Page 170 of 227
***Confidential***
2.c Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: C
HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861323
Page 171 of 227
***Confidential***
2.d Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: VO
MI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was complet
ed?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861324
Page 172 of 227
***Confidential***
2.e Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861325
Page 173 of 227
***Confidential***
2.f Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861326
Page 174 of 227
***Confidential***
2.g Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861327
Page 175 of 227
***Confidential***
2.h Symptom:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Injection Site
Reaction::RE
D
N
ESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861328
Page 176 of 227
***Confidential***
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861329
Page 177 of 227
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TE
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861330
Page 178 of 227
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-07-2020
19:15:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861331
Page 179 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020
19:15:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/7/2020Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020
19:15:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Ide
ntifier::1
Temperatu
re:36.8
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-07-2020
19:15:15
(UTC-03:00) CityACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861332
Page 180 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-07-2020
19:15:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-07-2020
19:15:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-07-2020
19:15:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861333
Page 181 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020
19:15:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020
19:15:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
09:42:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-08-2020
06:07:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861334
Page 182 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Sep-07-2020
19:15:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-07-2020
19:15:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection
:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
09:42:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BP1TM
8Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861335
Page 183 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-08-2020
09:42:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BP1TM8Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861336
Page 184 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 ACV0PFEINFP6000  Martina Data Entry: Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861337
Page 185 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
19:15:37
(UTC-03:00) City
of Buenos AiresDavalli Sep/7/2020 18:40
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861338
Page 186 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-07-2020
19:15:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861339
Page 187 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020
13:22:24
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861340
Page 188 of 227
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861341
Page 189 of 227
***Confidential***
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861342
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***Confidential***
2.b Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861343
Page 191 of 227
***Confidential***
2.c Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861344
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***Confidential***
2.d Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861345
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***Confidential***
2.e Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861346
Page 194 of 227
***Confidential***
2.f Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861347
Page 195 of 227
***Confidential***
2.g Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861348
Page 196 of 227
***Confidential***
2.h Symptom:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SSInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861349
Page 197 of 227
***Confidential***
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
O
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861350
Page 198 of 227
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON
SITE
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861351
Page 199 of 227
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020
13:22:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0861352
Page 200 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
13:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
13:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
16:37:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-07-2020
15:38:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861353
Page 201 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
13:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-07-2020
13:22:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:37:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BNVB2
6Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861354
Page 202 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-07-2020
16:37:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNVB26Initial Entry
5.b
Date Location User Value Reason
Oct-07-2020
17:24:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BNV33
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020
17:24:40
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BNV331Initial Entry
5.c
Date Location User Value Reason
Oct-07-2020
18:00:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPW75
9Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861355
Page 203 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Sample ID
Date Location User Value Reason
Oct-07-2020
18:00:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPW759Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861356
Page 204 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020
21:24:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020
21:24:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020
21:24:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861357
Page 205 of 227
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-25-2021
12:33:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-25-2021
12:33:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-25-2021
12:33:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PROTOCOL DEVIAT
IONInitial Entry
4. Specify Status:
Date Location User Value Reason
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861358
Page 206 of 227
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-25-2021
12:33:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
The volunteer was giv
en a vaccine not relate
d to the studyInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861359
Page 207 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021
15:51:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/12/2021Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861360
Page 208 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021
15:51:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is NOT wil
ling to return for Vacci
nation 3 OR otherwise
not eligibleInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861361
Page 209 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861362
Page 210 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-13-2021
15:37:27
(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
Jan-26-2021
01:20:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Close
dResponse
satisfies query
Jan-19-2021
14:38:15
(UTC-03:00)ACV0PFEINFP6000  Marjorie
BuonannoQuery 3: Close
dResponse
satisfies query
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861363
Page 211 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
City of Buenos
Aires
Jan-18-2021
16:46:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answ
eredthe patient has
not presented
any clinical
signs or
symptoms
associated with
adenocarcinoma
of the prostate.
He only has a
medical history
of elevated PSA
and has never
been diagnosed
with benign
prostatic
hypertrophy.
Jan-18-2021
09:09:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 3: Reiss
ued:OpenedThank you for
your response
however it does
not answer the
questions. Were
there any clinical
signs or
symptoms
leading to the
diagnosis of
prostate CA?
Jan-18-2021 ACV0PFEINFP6000  Marjorie Query 1: Close Response
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861364
Page 212 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
09:08:17
(UTC-03:00)
City of Buenos
AiresBuonanno d satisfies query
Jan-17-2021
18:24:48
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answ
eredFollow up SAE
form was sent
clarifying start
dates of the
patient's history
(hypertension
and PSA
elevation).
Jan-17-2021
18:22:32
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answ
eredMedical history
was updated.
Jan-16-2021
19:21:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answ
eredThe patient
began prostate
radiotherapy on
11 JAN 2021 (39
sessions will be
completed)
Jan-15-2021
16:59:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Marjorie
BuonannoQuery 3: Open
edGPD Clin:
Please confirm if
subject had any
clinical signs
associated with
prostate
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861365
Page 213 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
adenocarcinoma,
e.g. urinary
obstruction,
difficulty
urinating? Any
diagnosis of
benign prostatic
hypertrophy?
Jan-15-2021
15:19:52
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Open
edCLINICAL SAE
report prior Med
History section
includes
Hypertension;
however start
date does not
match recorded
Med Hx HTN
onset on
1/1/2005. BP
meds in SAE
report started
2005; please
review HTN
onset date;
update in a SAE
followup report
if appropriate
Jan-15-2021
14:16:59
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Marjorie
BuonannoQuery 1: Open
edGPD Clin: The
SAE narrative
submitted states
the subject had
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861366
Page 214 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aires medical history
of elevated PSA
since 2018 and
was followed by
urologist. Please
add elevated
PSA to medical
history once DM
unlocks med
history CRF
page.
Jan-13-2021
15:37:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Prostate adeno
carcinoma.Initial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/20/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021
04:15:57ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861367
Page 215 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of Buenos
Aires
Feb-26-2021
15:50:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answer
edThere are no
more data on the
adverse event
prostate
adenocarcinoma,
because the
subject withdrew
from the study
due to having
received a
vaccine not
related to the
study.
Feb-25-2021
12:33:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form
is completed and
this Adverse
Event is still
ongoing. Please
review and
update as
appropriate.
Jan-13-2021
15:37:27
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861368
Page 216 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
6. Toxicity Grade:
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-18-2021
07:06:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Prostate
adenocarcinoma.:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861369
Page 217 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anomal
y or birth defect?
NO
Did this serious e
vent result in deat
h?
NO
Did this serious e
vent require or pr
olong hospitalizat
ion?
NO
Did this serious e
vent result in pers
istent or significa
nt disability/incap
acity?
NO
Is this serious eve
nt life threateningInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861370
Page 218 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
?
NO
Other medically i
mportant serious
event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861371
Page 219 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-29-2021
08:36:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew
Information
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861372
Page 220 of 227
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-13-2021
15:37:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-18-2021
07:06:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021028480Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861373
Page 221 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Feb-25-2021
12:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861374
Page 222 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-25-2021
12:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Feb-25-2021
12:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-25-2021
12:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861375
Page 223 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Feb-25-2021
12:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Gam-COVID-Vac (tra
de name Sputnik V).Initial Entry
5. Date:
Date Location User Value Reason
Feb-25-2021
12:35:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/18/2021Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861376
Page 224 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-18-2021
18:20:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Closed per site response
Mar-17-2021
15:03:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered No unblinding
was performed
prior to the
volunteer
receiving a
Non-study
covid-19
vaccine. Thank
you
Mar-17-2021
10:57:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Non-study
covid-19
vaccine
reported. No
Treatment
Unblind is
reported for this
subject before
the
discontinuation
from study.
Please review if
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861377
Page 225 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
correct; else
update page if
subject was
informed of Rx
assignment
before end of
study
Feb-25-2021
12:33:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-09-2020
21:24:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-15-2020
21:09:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RAN
DOMIZEDInitial Entry
Aug-15-2020
18:30:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-25-2021
12:33:26
(UTC-03:00) CityACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/24/2021Initial Entry
090177e196ae2e95\Final\Final On: 01-Apr-2021 03:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861378
Page 226 of 227
***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: 12311379 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
Oct-09-2020
21:24:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc
…[truncated]