125742 S1 M5 CRF c4591001 1231 12311128

Document text

Page 1 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858564
Page 2 of 214
***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: 12311128 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/13/2020
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858565
Page 3 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311128]
2.Birth Date: /1976
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858566
Page 4 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858567
Page 5 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858568
Page 6 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858569
Page 7 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858570
Page 8 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858571
Page 9 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858572
Page 10 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858573
Page 11 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858574
Page 12 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858575
Page 13 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [70.4]
3.Unit: kg
4.Height: [168.0]
5.Unit: cm
6.Body Mass Index: [24.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858576
Page 14 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [48524]
3.Randomization Group: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858577
Page 15 of 214
***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: 12311128 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/13/2020
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 [BLCKBB]
5.bSample ID [BLCKBC]
5.cSample ID [BM83MF]
5.dSample ID [BM83MG]
5.eSample ID [BM83MH]
5.fSample ID [BLCKBD]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858578
Page 16 of 214
***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: 12311128 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/13/2020
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 [BM83KS]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858579
Page 17 of 214
***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: 12311128 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/13/2020 12:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858580
Page 18 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858581
Page 19 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858582
Page 20 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858583
Page 21 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858584
Page 22 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858585
Page 23 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858586
Page 24 of 214
***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: 12311128 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/2/2020
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 [BP25W3]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858587
Page 25 of 214
***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: 12311128 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/2/2020 09:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858588
Page 26 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858589
Page 27 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858590
Page 28 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858591
Page 29 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858592
Page 30 of 214
***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: 12311128 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/1/2020
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 [BK6XG5]
5.bSample ID [BK6XFP]
5.cSample ID [BPXJ2R]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858593
Page 31 of 214
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858594
Page 32 of 214
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12311128 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:
Feb/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR219N]
5.bSample ID [BRZ16K]
5.cSample ID [BRZ163]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858595
Page 33 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858596
Page 34 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858597
Page 35 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858598
Page 36 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858599
Page 37 of 214
***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: 12311128 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:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858600
Page 38 of 214
***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: 12311128 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: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858601
Page 39 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858602
Page 40 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858603
Page 41 of 214
***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: 12311128 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?
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858604
Page 42 of 214
***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: 12311128 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:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858605
Page 43 of 214
***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: 12311128 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:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858606
Page 44 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858607
Page 45 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858608
Page 46 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858609
Page 47 of 214
***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: 12311128 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/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858610
Page 48 of 214
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858611
Page 49 of 214
***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: 12311128 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:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858612
Page 50 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858613
Page 51 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858614
Page 52 of 214
***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: 12311128 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:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858615
Page 53 of 214
***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: 12311128 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?
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858616
Page 54 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858617
Page 55 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858618
Page 56 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858619
Page 57 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858620
Page 58 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858621
Page 59 of 214
***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: 12311128 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 [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858622
Page 60 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858623
Page 61 of 214
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 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 willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858624
Page 62 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT 1  Right index finger co
llateral nerve lesion Oct/8/20
20 10:00 NO
End Date Time:
Dec/9/2020 10:0
0
 Repeating
Pages
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858625
Page 63 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 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)[Right index finger collateral nerve lesion]
4.Start Date Time: Oct/8/2020 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/9/2020 10:00
6.Toxicity Grade: 3
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858626
Page 64 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 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:
[trauma to the right index finger with a gate]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858627
Page 65 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021209536]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858628
Page 66 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858629
Page 67 of 214
***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: 12311128 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[ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858630
Page 68 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858631
Page 69 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 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.Date: //
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858632
Page 70 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858633
Page 71 of 214
***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: 12311128 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?
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858634
Page 72 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858635
Page 73 of 214
***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: 12311128 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?
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858636
Page 74 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858637
Page 75 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858638
Page 76 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858639
Page 77 of 214
***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: 12311128 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?
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858640
Page 78 of 214
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858641
Page 79 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858642
Page 80 of 214
***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: 12311128 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: [ ]
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858643
Page 81 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/1/2020
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858644
Page 82 of 214
***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: 12311128 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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858645
Page 83 of 214
***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: 12311128 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-02-2021 16:16:14 (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.
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858646
Page 84 of 214
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-13-2020 13:24:34 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858647
Page 85 of 214
***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: 12311128 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-02-2021 16:16:14 (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 13:29:15 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-22-2021 21:57:49 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858648
Page 86 of 214
***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: 12311128 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 Feb-19-2021 11:51:02 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-12-2020 15:24:05 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858649
Page 87 of 214
***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: 12311128 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.
 N/A Oct-01-2020 15:52:24 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Sep-22-2020 11:54:09 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858650
Page 88 of 214
***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: 12311128 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.
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858651
Page 89 of 214
***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: 12311128 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-13-2020
13:18:36
(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-13-2020
13:18:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858652
Page 90 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020
13:18:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/13/2020Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858653
Page 91 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020
11:08:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311128Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020
11:07:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1976Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020
13:19:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0858654
Page 92 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
13:19:50
(UTC-03:00) City
of Buenos AiresHISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020
13:19:50
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858655
Page 93 of 214
***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: 12311128 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-13-2020
13:21:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858656
Page 94 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or female
participants bet
ween the ages o
f 18 and 55 yea
rs, inclusive, 65
and 85 years, in
clusive, or 18 a
nd 85 years, inc
lusive, at rando
mization (depe
ndent upon stud
y stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858657
Page 95 of 214
***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: 12311128 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):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partici
pants between the age
s of 18 and 55 years, i
nclusive, 65 and 85 y
ears, inclusive, or 18
and 85 years, inclusiv
e, at randomization (d
ependent upon study s
tage)Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858658
Page 96 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.a Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(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-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858659
Page 97 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing an
d able to compl
y with all sche
duled visits, va
ccination plan,
laboratory tests
, lifestyle consi
derations, and
other study pro
cedures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858660
Page 98 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858661
Page 99 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are
determined by
medical history
, physical exam
ination, and cli
nical judgment
of the investiga
tor to be eligibl
e for inclusion
in the study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858662
Page 100 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858663
Page 101 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined b
y medical history, phy
sical examination, an
d clinical judgment of
the investigator to be
eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858664
Page 102 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n Nu
mbe
r:4
Crit
erio
n De
scri
ptio
n:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the r
equirements an
d restrictions li
sted in the ICD
and in this prot
ocol
Crit
erio
n me
t?:YESInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858665
Page 103 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858666
Page 104 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving per
sonal signed informed
consent, which includ
es compliance with th
e requirements and re
strictions listed in the
ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858667
Page 105 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. r
ecent (within p
ast year) or acti
ve suicidal idea
tion/behavior/l
ab abnormality
that may increa
se the risk of st
udy participatio
nInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858668
Page 106 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n m
et?:NO
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past ye
ar) or active suicidal i
deation/behavior/lab aInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858669
Page 107 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
bnormality that may i
ncrease the risk of stu
dy participation
2.a Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:2Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858670
Page 108 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion
Descr
iptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858671
Page 109 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (H
BV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858672
Page 110 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:3
Crit
erio
n De
scri
ptio
n:History of seve
re adverse reac
tion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylaxi
s) to any comp
onent of the stu
dy intervention
(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858673
Page 111 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858674
Page 112 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adv
erse reaction associate
d with a vaccine and/
or severe allergic reac
tion (eg, anaphylaxis)
to any component of t
he study intervention(
s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858675
Page 113 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descri
ption:Receipt of
medication
s intended t
o prevent C
OVID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858676
Page 114 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(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-13-2020
13:22:25
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858677
Page 115 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.e
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with know
n or suspected
immunodeficie
ncy, as determi
ned by history
and/or laborato
ry/physical exa
mination
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858678
Page 116 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858679
Page 117 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised
individuals with know
n or suspected immun
odeficiency, as deter
mined by history and/
or laboratory/physical
examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858680
Page 118 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scrip
tion:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inves
tigator, contrai
ndicate intram
uscular injectio
n
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858681
Page 119 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858682
Page 120 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the
opinion of the investi
gator, contraindicate i
ntramuscular injectio
nInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858683
Page 121 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or br
eastfeedin
g
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX11A00Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858684
Page 122 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.g Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(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-13-2020
13:22:25
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858685
Page 123 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.h
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX12A00Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858686
Page 124 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(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-13-2020
13:22:25
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858687
Page 125 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.i
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858688
Page 126 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemic
corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858689
Page 127 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of bloo
d/plasma prod
ucts or immun
oglobulin, fro
m 60 days befo
re study interv
ention adminis
tration or plann
ed receipt thro
ughout the stud
y
Crit
erio
n me
t?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858690
Page 128 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (Fo
r Pfi
zer u
se o
nly):EX14A01
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858691
Page 129 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858692
Page 130 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858693
Page 131 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studies
involving stud
y intervention
within 28 day
s prior to stud
y entry and/or
during study p
articipation
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858694
Page 132 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858695
Page 133 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous part
icipation in o
ther studies i
nvolving stud
y interventio
n containing l
ipid nanopart
icles
Crite
rion
met?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858696
Page 134 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858697
Page 135 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.l Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858698
Page 136 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:22
Crit
erio
n D
escr
iptio
n:Investigator sit
e staff or Pfizer
employees dire
ctly involved i
n the conduct o
f the study, site
staff otherwise
supervised by t
he investigator,
and their respe
ctive family m
embers
Crit
erio
n m
et?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858699
Page 137 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX21A01
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858700
Page 138 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees d
irectly involved in th
e conduct of the study
, site staff otherwise s
upervised by the inve
stigator, and their res
pective family memb
ersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858701
Page 139 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-13-2020
13:22:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858702
Page 140 of 214
***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: 12311128 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-13-2020
13:24:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020
13:24:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020
13:24:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858703
Page 141 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
70.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858704
Page 142 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
168.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.9Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.2Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858705
Page 143 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858706
Page 144 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858707
Page 145 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020
13:25:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020
13:25:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
48524Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858708
Page 146 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
13:25:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
13:25:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020
13:52:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
13:25:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858709
Page 147 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Aug-13-2020
13:25:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
13:52:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCKB
BInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
13:52:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCKBBInitial Entry
5.b
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858710
Page 148 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:52:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCKB
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020
13:52:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCKBCInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020
13:53:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83M
FInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020
13:53:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83MFInitial Entry
5.d
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858711
Page 149 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-13-2020
13:53:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83M
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020
13:53:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83MGInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020
13:54:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BM83M
HInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020
13:54:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83MHInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858712
Page 150 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.f
Date Location User Value Reason
Aug-15-2020
13:07:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BLCKB
DInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-15-2020
13:07:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCKBDInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858713
Page 151 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020
13:26:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
13:26:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020
13:54:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
13:26:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858714
Page 152 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Aug-13-2020
13:26:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
13:54:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BM83K
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
13:54:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BM83KSInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858715
Page 153 of 214
***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: 12311128 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-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0858716
Page 154 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
13:26:29
(UTC-03:00) City
of Buenos AiresAug/13/2020 12:36
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858717
Page 155 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:26:29
(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-13-2020
13:26:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858718
Page 156 of 214
***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: 12311128 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-13-2020
13:26:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858719
Page 157 of 214
***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: 12311128 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-02-2020
10:50:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858720
Page 158 of 214
***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: 12311128 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-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858721
Page 159 of 214
***Confidential***
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020
10:51:07
(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 l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858722
Page 160 of 214
***Confidential***
2.b Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858723
Page 161 of 214
***Confidential***
2.c Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858724
Page 162 of 214
***Confidential***
2.d Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-02-2020
10:51:07
(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 S
ubject Diary wa
s completed?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858725
Page 163 of 214
***Confidential***
2.e Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858726
Page 164 of 214
***Confidential***
2.f Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858727
Page 165 of 214
***Confidential***
2.g Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D 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-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-02-2020
10:51:07
(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 las
t day the Sub
ject Diary wa
s completed?
:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858728
Page 166 of 214
***Confidential***
2.h Symptom:
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D 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-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SSInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858729
Page 167 of 214
***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
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858730
Page 168 of 214
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020
10:51:07
(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
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITE
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858731
Page 169 of 214
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020
10:51:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858732
Page 170 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
10:51:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020
10:51:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.4
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
10:51:28
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858733
Page 171 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
2.a Temperature:
Date Location User Value Reason
Sep-02-2020
10:51:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020
10:51:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
10:51:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858734
Page 172 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020
10:51:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020
10:51:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
09:56:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-02-2020
16:17:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858735
Page 173 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Sep-02-2020
10:51:45
(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-02-2020
10:51:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
09:56:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BP25
W3Initial Entry
5.a Sample ID
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858736
Page 174 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-03-2020
09:56:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BP25W3Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858737
Page 175 of 214
***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: 12311128 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-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0858738
Page 176 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10:52:05
(UTC-03:00) City
of Buenos AiresSep/2/2020 09:55
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858739
Page 177 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-02-2020
10:52:05
(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-02-2020
10:52:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858740
Page 178 of 214
***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: 12311128 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-09-2020
04:44:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-08-2020
17:13:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Answere
dThe form in
question is
already
loaded. Thank
you.
Oct-07-2020
23:30:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Erica Weaver Query 1: Opened DM: Per CRF
guidelines, the
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination
(Visit 3 date).
As Visit 3 is
now reached,
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0858741
Page 179 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
please
complete the
EOT form
accordingly.
Oct-01-2020
15:52:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0858742
Page 180 of 214
***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: 12311128 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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020
15:54:10
(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 l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858743
Page 181 of 214
***Confidential***
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858744
Page 182 of 214
***Confidential***
2.b Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858745
Page 183 of 214
***Confidential***
2.c Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858746
Page 184 of 214
***Confidential***
2.d Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858747
Page 185 of 214
***Confidential***
2.e Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858748
Page 186 of 214
***Confidential***
2.f Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858749
Page 187 of 214
***Confidential***
2.g Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-01-2020
15:54:10
(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 las
t day the Sub
ject Diary w
as completed
?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858750
Page 188 of 214
***Confidential***
2.h Symptom:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Oct-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SSInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858751
Page 189 of 214
***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-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020
15:54:10
(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
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858752
Page 190 of 214
***Confidential***
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITE
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858753
Page 191 of 214
***Confidential***
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
15:54:10
(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-01-2020
15:54:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0858754
Page 192 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
15:54:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
15:54:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020
09:38:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-02-2020
04:43:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858755
Page 193 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Oct-01-2020
15:54:32
(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-01-2020
15:54:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020
09:38:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BK6XG
5Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858756
Page 194 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Oct-02-2020
09:38:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BK6XG5Initial Entry
5.b
Date Location User Value Reason
Oct-02-2020
10:01:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BK6XF
PInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020
10:01:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BK6XFPInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
12:04:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPXJ2
RInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858757
Page 195 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.c Sample ID
Date Location User Value Reason
Oct-02-2020
12:04:43
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPXJ2RInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858758
Page 196 of 214
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021
15:16:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858759
Page 197 of 214
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021
15:17:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021
15:17:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021
15:46:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-26-2021
15:17:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858760
Page 198 of 214
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
are entered.
Please review
and correct as
appropriate.
Feb-26-2021
15:17:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021
15:46:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR219
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021
15:46:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR219NInitial Entry
5.b
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0858761
Page 199 of 214
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-26-2021
15:49:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRZ16
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021
15:49:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRZ16KInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021
15:50:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRZ16
3Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021
15:50:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRZ163Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0858762
Page 200 of 214
***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: 12311128 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-08-2020
17:13:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020
17:13:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020
17:13:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858763
Page 201 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021
11:51:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/19/2021Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858764
Page 202 of 214
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 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
Feb-19-2021
11:51:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing t
o return for Vaccinatio
n 3
Participant is:
eligible and NOT c
onfirmed to have re
ceived only placeb
o at Vaccination 1/
2Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858765
Page 203 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858766
Page 204 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Right index finger coll
ateral nerve lesionInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858767
Page 205 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/8/2020 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/9/2020 10:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858768
Page 206 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Feb-26-2021
06:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Right
index finger
collateral
nerve lesion:
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with cong
enital anomaly or bi
rth defect?
NO
Did this serious eve
nt result in death?Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858769
Page 207 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
NO
Did this serious eve
nt require or prolong
hospitalization?
NO
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically imp
ortant 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
Feb-25-2021
13:29:15
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858770
Page 208 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
of Buenos Aires
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHER
If Other, specify:
trauma to the rig
ht index finger w
ith a gateInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858771
Page 209 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-25-2021
13:29:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858772
Page 210 of 214
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Mar-01-2021
04:56:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2021209536Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0858773
Page 211 of 214
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-19-2021
11:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-19-2021
11:51:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0858774
Page 212 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-08-2020
17:13:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020
13:25:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-13-2020
13:24:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-08-2020
17:13:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
Aug-13-2020
13:25:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858775
Page 213 of 214
***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: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-13-2020
13:24:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0858776
Page 214 of 214
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano
Mayor Dr. Cosme Argerich
Subject No: 12311128 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-18-2020
20:32:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Gonzalo
Perez MarcData Entry:
Click Here to EnableInitial Entry
090177e196ae2eb0\Final\Final On: 01-Apr-2021 03:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0858777