125742 S1 M5 CRF c4591001 1231 12311448

Document text

Page 1 of 163
***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: 12311448 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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861820
Page 2 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/15/2020
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861821
Page 3 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12311448]
2.Birth Date: /1989
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861822
Page 4 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/15/2020
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861823
Page 5 of 163
***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: 12311448 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
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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861824
Page 6 of 163
***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: 12311448 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
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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861825
Page 7 of 163
***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: 12311448 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
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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861826
Page 8 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861827
Page 9 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depressive Syndrome due to Relative Passing Away]
Start Date: Jun/6/2008
Ongoing: NO
End Date:
Jun/1/2010
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Smoking]
Start Date: May/1/2014
Ongoing: YES
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861828
Page 10 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/15/2020
2.Weight: [55.3]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [18.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861829
Page 11 of 163
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861830
Page 12 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/15/2020
2.Randomization Number: [51586]
3.Randomization Group: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861831
Page 13 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP14JW]
5.bSample ID [BP14JX]
5.cSample ID [BP14M0]
5.dSample ID [BLCVSS]
5.eSample ID [BLCVST]
5 fSample ID [BLCVSV]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861832
Page 14 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/15/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP14WC]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861833
Page 15 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/15/2020 19:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861834
Page 16 of 163
***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: 12311448 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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861835
Page 17 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/7/2020
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861836
Page 18 of 163
***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: 12311448 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
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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861837
Page 19 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861838
Page 20 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Sep/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861839
Page 21 of 163
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861840
Page 22 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/7/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2D50]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861841
Page 23 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/7/2020 19:40
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861842
Page 24 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861843
Page 25 of 163
***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: 12311448 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
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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861844
Page 26 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861845
Page 27 of 163
***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: 12311448 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/6/2020
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 [BLBY6T]
5.bSample ID [BLBY6V]
5.cSample ID [BK6XT2]
5.dSample ID [BP1VHC]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861846
Page 28 of 163
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861847
Page 29 of 163
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861848
Page 30 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861849
Page 31 of 163
***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: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861850
Page 32 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861851
Page 33 of 163
***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: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861852
Page 34 of 163
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311448 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:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861853
Page 35 of 163
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311448 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: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861854
Page 36 of 163
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861855
Page 37 of 163
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861856
Page 38 of 163
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311448 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?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861857
Page 39 of 163
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 12311448 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:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861858
Page 40 of 163
***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: 12311448 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:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861859
Page 41 of 163
***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: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861860
Page 42 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861861
Page 43 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861862
Page 44 of 163
***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: 12311448 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/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861863
Page 45 of 163
***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: 12311448 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: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861864
Page 46 of 163
***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: 12311448 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:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861865
Page 47 of 163
***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: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861866
Page 48 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861867
Page 49 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861868
Page 50 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861869
Page 51 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861870
Page 52 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861871
Page 53 of 163
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861872
Page 54 of 163
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861873
Page 55 of 163
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861874
Page 56 of 163
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861875
Page 57 of 163
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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 [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861876
Page 58 of 163
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861877
Page 59 of 163
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861878
Page 60 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Exposure during Pregna
ncy Nov/9/2020 08:
30 YES  Repeating
Pages
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861879
Page 61 of 163
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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)[Exposure during Pregnancy]
4.Start Date Time: Nov/9/2020 08:30
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861880
Page 62 of 163
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
13.What was the outcome of this adverse
event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861881
Page 63 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861882
Page 64 of 163
***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: 12311448 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[ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861883
Page 65 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861884
Page 66 of 163
***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: 12311448 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: //
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861885
Page 67 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861886
Page 68 of 163
***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: 12311448 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?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861887
Page 69 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861888
Page 70 of 163
***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: 12311448 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?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861889
Page 71 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861890
Page 72 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861891
Page 73 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861892
Page 74 of 163
***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: 12311448 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?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861893
Page 75 of 163
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861894
Page 76 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861895
Page 77 of 163
***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: 12311448 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: [ ]
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861896
Page 78 of 163
***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: 12311448 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/6/2020
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861897
Page 79 of 163
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12311448 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
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861898
Page 80 of 163
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12311448 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 Feb-11-2021 20:36:47 (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.
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861899
Page 81 of 163
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Dec-30-2020 12:17:40 (UTC-03:00) City of Buenos
AiresSantiago
CorradettiNot Applicable
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861900
Page 82 of 163
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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 Feb-11-2021 20:36:47 (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-08-2021 11:09:25 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Jan-21-2021 11:39:23 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, MariaBeretta, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-30-2020 10:25:21 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando Polack  Approved Oct-22-2020 15:20:33 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0861901
Page 83 of 163
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 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.
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861902
Page 84 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-15-2020 17:51:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-15-2020 17:51:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861903
Page 85 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-15-2020 17:51:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/15/2020Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861904
Page 86 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-15-2020 17:51:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12311448Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 12:32:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
/1989Transcription Error
Aug-15-2020 17:51:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-15-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-15-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-15-2020 17:51:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (6)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861905
Page 87 of 163
***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: 12311448 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-16-2020 11:39:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861906
Page 88 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 y
ears, inclusive, at randomizat
ion (dependent upon study st
age)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants between t
he ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and 8
5 years, inclusive, at randomization (d
ependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861907
Page 89 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 11:39:40
(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-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifestyl
e considerations, and other st
udy procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN02A00Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861908
Page 90 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, vac
cination plan, laboratory tests, lifestyle
considerations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inve
stigator to be eligible for incl
usion in the studyInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861909
Page 91 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are determin
ed by medical history, physical exami
nation, and clinical judgment of the in
vestigator to be eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi4Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861910
Page 92 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
on Nu
mber:
Criteri
on Desc
ription:Capable of giving personal s
igned informed consent, whi
ch includes compliance with
the requirements and restrict
ions listed in the ICD and in
this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN04A00
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861911
Page 93 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed info
rmed consent, which includes complia
nce with the requirements and restricti
ons listed in the ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ris
k of study participationInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861912
Page 94 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnorm
ality that may increase the risk of stud
y participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(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-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861913
Page 95 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency viru
s (HIV), hepatitis C virus (
HCV), or hepatitis B virus
(HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human immuno
deficiency virus (HIV), hepatitis C vir
us (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861914
Page 96 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse re
action associated with a vac
cine and/or severe allergic re
action (eg, anaphylaxis) to a
ny component of the study i
ntervention(s)
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX03A00Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861915
Page 97 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction ass
ociated with a vaccine and/or severe al
lergic reaction (eg, anaphylaxis) to an
y component of the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preven
t COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861916
Page 98 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(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-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:8
Criterio
n Descr
iption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinati
on
Criterio
n met?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861917
Page 99 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with
known or suspected immunodeficienc
y, as determined by history and/or lab
oratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861918
Page 100 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Desc
ription:Bleeding diathesis or conditi
on associated with prolonge
d bleeding that would, in the
opinion of the investigator, c
ontraindicate intramuscular i
njection
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associ
ated with prolonged bleeding that wou
ld, in the opinion of the investigator, c
ontraindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861919
Page 101 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:11
Criterion Descri
ption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfee
dingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(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-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861920
Page 102 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires Exclusion Nu
mber:12
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronav
irus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(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-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:13Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861921
Page 103 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
Descripti
on:Subjects who receive imm
unosuppressive therapy, s
uch as cytotoxic agents or
systemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppress
ive therapy, such as cytotoxic agents o
r systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
Exclusi15Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861922
Page 104 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires on Num
ber:
Criteri
on Desc
ription:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study int
ervention administration or
planned receipt throughout t
he study
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or pl
anned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861923
Page 105 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studi
es involving study interven
tion within 28 days prior to
study entry and/or during s
tudy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX15A01Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861924
Page 106 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies involvin
g study intervention within 28 days pr
ior to study entry and/or during study
participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in
other studies involving st
udy intervention containi
ng lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861925
Page 107 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other studies
involving study intervention containin
g lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861926
Page 108 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Investigator site staff or Pfiz
er employees directly involv
ed in the conduct of the stud
y, site staff otherwise supervi
sed by the investigator, and t
heir respective family memb
ers
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861927
Page 109 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employ
ees directly involved in the conduct of
the study, site staff otherwise supervis
ed by the investigator, and their respe
ctive family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-16-2020 11:39:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861928
Page 110 of 163
***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: 12311448 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-16-2020 11:39:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-16-2020 11:39:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-16-2020 11:39:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861929
Page 111 of 163
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-16-2020 11:41:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Depressive Syndrome du
e to Relative Passing Aw
ay
Start Date: Jun/6/2008
Ongoing: NO
End Date:
Jun/1/2010Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-16-2020 11:41:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-16-2020 11:41:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Depressive Syndrome due to Relative
Passing AwayInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-16-2020 11:41:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jun/6/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-16-2020 11:41:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861930
Page 112 of 163
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Jun/1/2010
1.b
Date Location User Value Reason
Aug-16-2020 11:42:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term: Smoking
Start Date: May/1/2014
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-16-2020 11:42:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-16-2020 11:42:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SmokingInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-16-2020 11:42:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
May/1/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-16-2020 11:42:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861931
Page 113 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
55.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
172.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18.7Initial Entry
7.a
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861932
Page 114 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locatio
n::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-16-2020 11:42:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861933
Page 115 of 163
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861934
Page 116 of 163
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-16-2020 11:42:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861935
Page 117 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-16-2020 11:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020Initial Entry
2. Randomization Number:
Date Location User ValueReason
Aug-17-2020
14:46:25
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by Validation
Check: VC_DS001_07
Aug-17-2020
12:33:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Aug-17-2020
12:33:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
51586Transcription Error
Aug-17-2020
04:16:26
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4209088;Randomization
Number appears to be a
duplicate with Subject
12311451. Please confirm the
number has been entered
correctly or clarify.
Aug-16-2020
11:43:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
51565Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861936
Page 118 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020 11:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020 11:43:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 10:55:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-16-2020 11:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-16-2020 11:43:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 10:55:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP14JWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861937
Page 119 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-17-2020 10:55:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP14JWInitial Entry
5.b
Date Location User Value Reason
Aug-17-2020 10:55:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP14JXInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 10:55:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP14JXInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020 11:00:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP14M0Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 11:00:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP14M0Initial Entry
5.d
Date Location User Value Reason
Aug-23-2020 19:36:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCVSSInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861938
Page 120 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d Sample ID
Date Location User Value Reason
Aug-23-2020 19:36:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVSSInitial Entry
5.e
Date Location User Value Reason
Aug-23-2020 19:36:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCVSTInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-23-2020 19:36:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVSTInitial Entry
5.f
Date Location User Value Reason
Aug-23-2020 19:37:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCVSVInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-23-2020 19:37:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCVSVInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861939
Page 121 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-16-2020 11:43:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-16-2020 11:43:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-16-2020 13:46:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-16-2020 11:43:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-16-2020 11:43:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/15/2020Initial Entry
5.a
Date Location User Value Reason
Aug-16-2020 13:46:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP14WCInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861940
Page 122 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-16-2020 13:46:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP14WCInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861941
Page 123 of 163
***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: 12311448 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-16-2020 11:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/15/2020 19:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861942
Page 124 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-16-2020 11:43:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-16-2020 11:43:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861943
Page 125 of 163
***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: 12311448 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-16-2020 11:43:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJEC
TInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861944
Page 126 of 163
***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: 12311448 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-08-2020 08:10:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861945
Page 127 of 163
***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: 12311448 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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861946
Page 128 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-08-2020 08:11:18 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861947
Page 129 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresSymptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861948
Page 130 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-08-2020 08:11:18 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861949
Page 131 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresSymptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861950
Page 132 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Symptom:
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENED 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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861951
Page 133 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITEInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861952
Page 134 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020 08:11:18
(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-08-2020 08:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861953
Page 135 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 08:11:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 08:11:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 08:11:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 08:11:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 08:11:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 08:11:48 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861954
Page 136 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresORAL CAVITY
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861955
Page 137 of 163
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 08:11:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 08:11:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 08:12:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 08:11:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of collection is
reported, but result is
missing. Please review
and update as
appropriate.
Sep-08-2020 08:11:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020 08:11:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 08:11:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861956
Page 138 of 163
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - 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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
6.a
Date Location User Value Reason
Sep-08-2020 08:12:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
Sep-08-2020 08:11:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Define
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 08:12:57
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 08:11:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020 08:12:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861957
Page 139 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 08:12:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 08:12:05
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 15:15:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 10:56:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-08-2020 08:12:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-08-2020 08:12:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/7/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861958
Page 140 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-08-2020 15:15:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2D50Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 15:15:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2D50Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861959
Page 141 of 163
***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: 12311448 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-08-2020 08:12:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020 19:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861960
Page 142 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 08:12:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-08-2020 08:12:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861961
Page 143 of 163
***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: 12311448 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-06-2020 09:50:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861962
Page 144 of 163
***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: 12311448 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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
EInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861963
Page 145 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NO
2.b Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861964
Page 146 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.d
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sympt
oms present on the last day t
he Subject Diary was complet
ed?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861965
Page 147 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-06-2020 09:51:10 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861966
Page 148 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresSymptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861967
Page 149 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.h Symptom:
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR WORSENED 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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions p
resent on the last day the Subj
ect Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861968
Page 150 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SIT
EInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861969
Page 151 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 09:51:10
(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
Oct-06-2020 09:51:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861970
Page 152 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 09:51:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 09:51:33
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 12:04:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-06-2020 10:13:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-06-2020 09:51:33
(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-06-2020 09:51:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 12:04:50
(UTC-03:00) City ofACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BLBY6TInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861971
Page 153 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 12:04:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BLBY6TInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 12:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
Sample ID: BLBY6VInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 12:05:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Romina
BarreraData Entry:
BLBY6VInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 12:09:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BK6XT2Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 12:09:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BK6XT2Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020 13:46:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP1VHCInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861972
Page 154 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 13:46:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP1VHCInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861973
Page 155 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020 10:52:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-09-2020 08:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-09-2020 08:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
Oct-08-2020 16:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Please complete this
page
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 08:31:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 08:31:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861974
Page 156 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861975
Page 157 of 163
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-08-2021 17:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-08-2021 10:36:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Delivery date of prior
pregnancy : 27 Jul
2012. Safety update
was sent.
Jan-04-2021 18:15:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened Clinical Thank you;
however, SAE med
Hx condition #4 is
previous pregnancy
(gravida 1) with live
birth with no date.
Please submit
delivery date of prior
pregnancy in a Safety
update.
Jan-04-2021 16:24:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered This information is in
EDP. The patient had
no previous
pregnancies.
Dec-31-2020 13:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical Please
submit a SAE safety
update with the
delivery date for
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861976
Page 158 of 163
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
subject's prior
pregnancy, and Father
info (age,
smoke/drink, other) if
available.
Dec-30-2020 12:18:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiData Entry:
Exposure during PregnancyTranslation mistake
Dec-30-2020 10:25:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Drug Exposed PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-08-2021 11:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/9/2020 08:30New Information
Dec-30-2020 10:25:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/6/2020 08:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-30-2020 12:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiData Entry:
Not ApplicableInitial Entry
Dec-30-2020 12:17:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiData Entry: Transcription Error
Dec-30-2020 10:25:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861977
Page 159 of 163
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861978
Page 160 of 163
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-04-2021 05:43:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-30-2020 12:21:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Santiago
CorradettiQuery 1: Answered As per CRF
Completion
Requirements
(section 8.50.2.5), as
long as pregnancy is
still ongoing, the
outcome of the AE
should remain as
'unknown'. Thank
you.
Dec-30-2020 12:18:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Exposure
during Pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Dec-30-2020 10:25:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Drug
Exposed Pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861979
Page 161 of 163
***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
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-30-2020 10:25:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-30-2020 10:25:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0861980
Page 162 of 163
***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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020 08:31:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-16-2020 11:43:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-16-2020 11:39:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020 08:31:29
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Aug-16-2020 11:43:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/15/2020Initial Entry
Aug-16-2020 11:39:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/15/2020Initial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0861981
Page 163 of 163
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: 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: 12311448 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 15:20:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Fernando
PolackData Entry:
Click Here to EnableInitial Entry
090177e196ae2f19\Final\Final On: 01-Apr-2021 03:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0861982