Document text
Page 1 of 172
***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: 12312205 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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866687
Page 2 of 172
***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: 12312205 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/19/2020
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866688
Page 3 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Demography
1.Subject ID [12312205]
2.Birth Date: /1979
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0866689
Page 4 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866690
Page 5 of 172
***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: 12312205 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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866691
Page 6 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866692
Page 7 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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
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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866693
Page 8 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866694
Page 9 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866695
Page 10 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866696
Page 11 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [62.2]
3.Unit: kg
4.Height: [166.0]
5.Unit: cm
6.Body Mass Index: [22.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866697
Page 12 of 172
***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: 12312205 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/19/2020
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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866698
Page 13 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [55766]
3.Randomization Group: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866699
Page 14 of 172
***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: 12312205 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/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHWT13]
5.bSample ID [BHWT14]
5.cSample ID [BHWT15]
5.dSample ID [BPHYB3]
5.eSample ID [BPHYB4]
5.fSample ID [BPHYB5]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866700
Page 15 of 172
***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: 12312205 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/19/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHWV0F]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866701
Page 16 of 172
***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: 12312205 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/19/2020 10:23
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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866702
Page 17 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866703
Page 18 of 172
***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: 12312205 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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866704
Page 19 of 172
***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: 12312205 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: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866705
Page 20 of 172
***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: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866706
Page 21 of 172
***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: 12312205 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 [BP1TM4]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866707
Page 22 of 172
***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: 12312205 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 16:25
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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866708
Page 23 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866709
Page 24 of 172
***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: 12312205 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/5/2020
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 [BPCM8P]
5.bSample ID [BPCM9Z]
5.cSample ID [BPCMB0]
5.dSample ID [BPXHNL]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866710
Page 25 of 172
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866711
Page 26 of 172
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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:
Mar/2/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR23P1]
5.bSample ID [BNTZ6B]
5.cSample ID [BNTZ5T]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866712
Page 27 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866713
Page 28 of 172
***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: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866714
Page 29 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866715
Page 30 of 172
***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: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866716
Page 31 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866717
Page 32 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866718
Page 33 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866719
Page 34 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866720
Page 35 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866721
Page 36 of 172
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866722
Page 37 of 172
***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: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866723
Page 38 of 172
***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: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866724
Page 39 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866725
Page 40 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Unplanned Assessments
1.Assessments
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866726
Page 41 of 172
***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: 12312205 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/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866727
Page 42 of 172
***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: 12312205 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: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866728
Page 43 of 172
***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: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866729
Page 44 of 172
***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: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866730
Page 45 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866731
Page 46 of 172
***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: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866732
Page 47 of 172
***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: 12312205 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:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866733
Page 48 of 172
***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: 12312205 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?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866734
Page 49 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866735
Page 50 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866736
Page 51 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866737
Page 52 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866738
Page 53 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866739
Page 54 of 172
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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 [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866740
Page 55 of 172
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial 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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866741
Page 56 of 172
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12312205 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?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866742
Page 57 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 exposure during preg
nancy Sep/29/2020 20
:00 NO
End Date Time:
Nov/29/2020 23:00
Repeating
Pages
2.ADVERSE EV
ENT 2 Spontaneous abortio
n Nov/26/2020 2
2:00 NO
End Date Time:
Nov/29/2020 23:00
Repeating
Pages
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866743
Page 58 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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: Sep/29/2020 20:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/29/2020 23:00
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:
[unplanned pregnancy]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866744
Page 59 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866745
Page 60 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Spontaneous abortion]
4.Start Date Time: Nov/26/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/29/2020 23:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866746
Page 61 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
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?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020442711]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866747
Page 62 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866748
Page 63 of 172
***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: 12312205 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[ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866749
Page 64 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866750
Page 65 of 172
***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: 12312205 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: //
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866751
Page 66 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866752
Page 67 of 172
***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: 12312205 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?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866753
Page 68 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866754
Page 69 of 172
***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: 12312205 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?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866755
Page 70 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866756
Page 71 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866757
Page 72 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866758
Page 73 of 172
***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: 12312205 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?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866759
Page 74 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866760
Page 75 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866761
Page 76 of 172
***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: 12312205 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: [ ]
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866762
Page 77 of 172
***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: 12312205 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/5/2020
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866763
Page 78 of 172
***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: 12312205 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
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866764
Page 79 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 16:54:01 (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.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0866765
Page 80 of 172
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
FormAug-19-2020 13:22:21 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866766
Page 81 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
ItemDate User Comment
6Nov-15-2020 10:35:14 (UTC-03:00) City of
Buenos AiresTatiana Estrada Not Applicable
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0866767
Page 82 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 16:54:01 (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 Mar-02-2021 12:57:01 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 02:50:31 (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 Dec-01-2020 06:51:52 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0866768
Page 83 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Approved Nov-30-2020 15:46:28 (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 Nov-29-2020 18:37:47 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-15-2020 18:20:25 (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.
Tatiana Estrada N/A Nov-15-2020 10:34:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-08-2020 10:39:13 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0866769
Page 84 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Affidavit:
By my dated signature below, I, SantiagoCorradetti, 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 Nov-07-2020 10:21:01 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-21-2020 20:19:15 (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.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0866770
Page 85 of 172
***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: 12312205 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-19-2020 13:17:56
(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-19-2020 13:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866771
Page 86 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020 13:18:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/19/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866772
Page 87 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020 10:10:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12312205Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020 10:10:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-19-2020 13:17:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020 13:17:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020 13:17:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866773
Page 88 of 172
***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: 12312205 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-19-2020 13:18:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866774
Page 89 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclusi
ve, at randomization (dep
endent upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, inc
lusive, 65 and 85 years, inclusive,Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866775
Page 90 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
or 18 and 85 years, inclusive, at ra
ndomization (dependent upon stud
y stage)
1.a Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wi
th all scheduled visits, va
ccination plan, laboratory
tests, lifestyle considerati
ons, and other study proc
edures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866776
Page 91 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.b Inclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and a
ble to comply with all scheduled v
isits, vaccination plan, laboratory t
ests, lifestyle considerations, and o
ther study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866777
Page 92 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866778
Page 93 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.c Inclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgmen
t of the investigator to be eligible f
or inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866779
Page 94 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requiremen
ts and restrictions listed i
n the ICD and in this prot
ocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866780
Page 95 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
1.d Inclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866781
Page 96 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condi
tion incl. recent (within past year)
or active suicidal ideation/behavio
r/lab abnormality that may increas
e the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866782
Page 97 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866783
Page 98 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.b Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatit
is C virus (HCV), or hepatitis B vi
rus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866784
Page 99 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe all
ergic reaction (eg, anaph
ylaxis) to any component
of the study intervention(
s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866785
Page 100 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.c Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction
associated with a vaccine and/or s
evere allergic reaction (eg, anaphy
laxis) to any component of the stu
dy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866786
Page 101 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu8Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866787
Page 102 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
mber:
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866788
Page 103 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.e Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histor
y and/or laboratory/physical exami
nationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866789
Page 104 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pr
olonged bleeding that wo
uld, in the opinion of the
investigator, contraindica
te intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866790
Page 105 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.f Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding th
at would, in the opinion of the inv
estigator, contraindicate intramusc
ular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeedingInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866791
Page 106 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion met
?:NO
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breast
feedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866792
Page 107 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterion De
scription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866793
Page 108 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic corti
costeroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866794
Page 109 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.i Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosupp
ressive therapy, such as cytotoxic
agents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866795
Page 110 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admin
istration or planned recei
pt throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866796
Page 111 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.j Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention administ
ration or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866797
Page 112 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
2.k
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criteri
on Desc
ription:Participation in other st
udies involving study in
tervention within 28 da
ys prior to study entry a
nd/or during study parti
cipation
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866798
Page 113 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.k Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies invol
ving study intervention within 28
days prior to study entry and/or du
ring study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866799
Page 114 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Criterio
n Descri
ption:Previous participation
in other studies involvi
ng study intervention c
ontaining lipid nanopa
rticles
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other stu
dies involving study intervention
containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866800
Page 115 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff other
wise supervised by the in
vestigator, and their respe
ctive family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866801
Page 116 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.m Exclusion Number:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer em
ployees directly involved in the co
nduct of the study, site staff other
wise supervised by the investigato
r, and their respective family mem
bersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-19-2020 13:18:50
(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-19-2020 13:18:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866802
Page 117 of 172
***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: 12312205 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-19-2020 13:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020 13:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020 13:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866803
Page 118 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
62.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
166.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866804
Page 119 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.6Initial Entry
7.a
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020 13:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866805
Page 120 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866806
Page 121 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-19-2020 13:23:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866807
Page 122 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020 13:23:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020 13:23:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
55766Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866808
Page 123 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 13:24:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 13:24:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 13:23:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-19-2020 15:53:12
(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.
Aug-19-2020 13:24:00
(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-19-2020 13:24:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866809
Page 124 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Aug-22-2020 13:23:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWT13Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 13:23:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWT13Initial Entry
5.b
Date Location User Value Reason
Aug-22-2020 13:23:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWT14Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 13:23:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWT14Initial Entry
5.c
Date Location User Value Reason
Aug-22-2020 13:23:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWT15Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 13:23:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWT15Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866810
Page 125 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d
Date Location User Value Reason
Aug-22-2020 14:05:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPHYB3Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-22-2020 14:05:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPHYB3Initial Entry
5.e
Date Location User Value Reason
Aug-22-2020 14:05:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPHYB4Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-22-2020 14:05:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPHYB4Initial Entry
5.f
Date Location User Value Reason
Aug-22-2020 14:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
Sample ID: BPHYB5Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-22-2020 14:05:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Romina
BarreraData Entry:
BPHYB5Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0866811
Page 126 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020 13:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020 13:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-23-2020 10:14:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-19-2020 15:53:12
(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.
Aug-19-2020 13:24:10
(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-19-2020 13:24:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/19/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866812
Page 127 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Aug-23-2020 10:14:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHWV0FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-23-2020 10:14:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHWV0FInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866813
Page 128 of 172
***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: 12312205 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-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/19/2020 10:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866814
Page 129 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Aug-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-19-2020 13:24:45
(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-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-19-2020 13:24:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866815
Page 130 of 172
***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: 12312205 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-19-2020 13:24:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866816
Page 131 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 17:32:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866817
Page 132 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020 17:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020Initial Entry
2.a
Date Location User Value Reason
Sep-07-2020 17:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.7
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-07-2020 17:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-07-2020 17:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-07-2020 17:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866818
Page 133 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
2.a Temperature Location:
Date Location User Value Reason
Sep-07-2020 17:32:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866819
Page 134 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-07-2020 17:32:30
(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-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866820
Page 135 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-07-2020 17:32:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866821
Page 136 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 17:32:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 17:32:39
(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 11:11:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 03:00:49
(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-07-2020 17:32:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 17:32:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866822
Page 137 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep/7/2020
5.a
Date Location User Value Reason
Sep-08-2020 11:11:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP1TM4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 11:11:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP1TM4Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866823
Page 138 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/7/2020 16:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866824
Page 139 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-07-2020 17:33:04
(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-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-07-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866825
Page 140 of 172
***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: 12312205 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-15-2020 02:59:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-14-2020 12:24:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered EOT form
completed
Oct-13-2020 08:37:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened DM: Patient
completed the
treatment phase
and reached at
Visit 3. Kindly
consider to update
EOT form with
matching V3 date
or else clarify.
Thank you.
Oct-05-2020 13:13:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866826
Page 141 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 13:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 13:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 18:59:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 13:13:48
(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-05-2020 13:13:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 18:59:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPCM8PInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866827
Page 142 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 18:59:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPCM8PInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 09:27:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPCM9ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 09:27:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPCM9ZInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 09:28:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPCMB0Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 09:28:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPCMB0Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020 09:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPXHNLInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866828
Page 143 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 09:28:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPXHNLInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866829
Page 144 of 172
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 12:57:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/2/2021Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0866830
Page 145 of 172
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021 12:57:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021 12:57:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 09:30:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-03-2021 08:28:44
(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.
Mar-02-2021 12:57:15
(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.
Mar-02-2021 12:57:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/2/2021Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0866831
Page 146 of 172
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
5.a
Date Location User Value Reason
Mar-03-2021 09:30:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR23P1Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 09:30:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR23P1Initial Entry
5.b
Date Location User Value Reason
Mar-03-2021 09:42:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTZ6BInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021 09:42:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTZ6BInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021 10:46:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BNTZ5TInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-03-2021 10:46:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BNTZ5TInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866832
Page 147 of 172
***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: 12312205 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-14-2020 12:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 12:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020 12:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0866833
Page 148 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866834
Page 149 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0866835
Page 150 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-07-2020 10:21:01
(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
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
exposure during pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/29/2020 20:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-02-2020 18:52:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-02-2020 16:50:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-02-2020 16:50:23 ACV0PFEINFP6000 Data Entry: New Information
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866836
Page 151 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00) City of
Buenos AiresNO
End Date Time:
Nov/29/2020 23:00
Dec-01-2020 16:57:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL - please
update the exposure
during Pregnancy
END date when the
SAE in-progress
abortion is
complete
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-15-2020 12:46:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-15-2020 10:35:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry:
Not ApplicableInitial Entry
Nov-15-2020 10:34:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Nov-15-2020 10:34:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Tatiana
EstradaData Entry: Changed
Information
Nov-15-2020 03:42:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Balaji Prabu
R Query 1: Opened Toxicity grade is not
expected for
pregnancy related
adverse events,
hence please remove
the toxicity and add
item level comment
as NOT
APPLICABLE.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866837
Page 152 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-07-2020 10:21:01
(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
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
unplanned pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866838
Page 153 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-07-2020 10:21:01
(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
Dec-03-2020 09:53:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-03-2020 09:53:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDTranscription Error
Dec-02-2020 16:50:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: 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".
Nov-07-2020 13:21:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Unknown is the
correct outcome for
ongoing
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866839
Page 154 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
pregnancies
Nov-07-2020 11:36:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The pregnancy is an
ongoing event
Nov-07-2020 10:21:01
(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".
Nov-07-2020 10:21:01
(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
Nov-07-2020 10:21:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866840
Page 155 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Category:
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Dec-10-2020
13:10:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies query
Dec-09-2020
08:19:04
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Clo
sedResponse satisfies query
Dec-07-2020
20:48:42
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: An
swere
dSAE safety update was sent
on 03Dec with this
information
Dec-07-2020
07:53:04
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Rei
ssued:
Candi
datePending SDB update
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0866841
Page 156 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-06-2020
11:45:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dCLINICAL Thank you.
Please send a SAE safety
update for this completed
abortion, including the
additional information
'spontaneous' in the event
term
Dec-04-2020
10:59:56
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: An
swere
dOn 3Dec, follow-up SAE
form was sent whit this
updated.
Dec-04-2020
08:28:31
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
3: Op
enedSAE
RECON:AER#2020442711,
the term in AE CRF was
updated to 'Spontaneous
abortion' while retained as
'In progress abortion' in
SDB. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Dec-03-2020
18:16:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
2: An
swere
dNew Information
Dec-03-2020
18:16:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
Spont
aneou
s abor
tionNew Information
Dec-02-2020
18:49:18
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Rei
ssued:
Opene
dCLINICAL - please update
the 'In progress abortion'
term to include the
Spontaneous information.
Dec-02-2020
10:26:45ACV0PFEINFP6000 Query
2: AnI clarify that the abortion
was spontaneous.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866842
Page 157 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
(UTC-03:00)
City of
Buenos Airesswere
d
Dec-01-2020
16:46:12
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Query
2: Op
enedClinical - for coding
purposes, please specify in
the Event Term if the
abortion was induced or
spontaneous.
Nov-29-2020
20:26:19
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Nov-29-2020
19:32:22
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Nov-29-2020
19:32:22
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
In pro
gress
aborti
onTranscription Error
Nov-29-2020
19:28:47
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedSpacing: Verbatim Term
contains leading, trailing or
more than one consecutive
space.
Nov-29-2020
18:37:47
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000 Data
Entry
:
In Pro
gress
Aborti
onInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866843
Page 158 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-10-2020 13:14:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Dec-07-2020 20:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered SAE safety update
was sent on 03Dec
with this information
Dec-06-2020 11:44:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened Clinical Thank you.
Please send a SAE
safety update to
harmonize reporting
of this SAE start date
Dec-04-2020 13:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/26/2020 22:00New Information
Dec-03-2020 18:17:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Dec-03-2020 18:17:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/26/2020 22:00New Information
Dec-02-2020 19:09:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened CLINICAL In
Vaccine study, SAE
start date is day event
starts; not day it
meets serious
criteria. If
Spontaneous
abortion began with
'vaginal bleeding in
last 48 hrs as of
09Nov', enter that
date.
Dec-02-2020 11:07:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-02-2020 10:25:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(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), (b) (6)
FDA-CBER-2021-5683-0866844
Page 159 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-02-2020 10:25:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-02-2020 10:25:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/29/2020 UNK:UNKNew Information
Dec-01-2020 16:54:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened Clinical Start date is
26Nov20; however,
SAE start is
29SEP20. In Vaccine
study, SAE start date
is day event starts;
not day it meets
serious criteria (item
11 in vaccine SAE
instruct). If SAE
began as non-serious,
record that date as
the onset.
Dec-01-2020 16:51:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed will reword with
guidelines on SAE
that starts as AE
Dec-01-2020 16:47:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened Clinical Start date for
event in progress
Abortion is
26Nov2020;
however, SAE start
date for this event is
29SEP2020. Please
review, harmonize
reporting, and update
the start date in the
correct location.
Dec-01-2020 07:00:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020442711
,onset date was
recorded as
29Sep2020 in Safety
database however,
recorded as
26Nov2020 on AE
CRF. Please confirm
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866845
Page 160 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/26/2020 23:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-06-2020 11:45:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-04-2020 13:16:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-04-2020 13:16:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/29/2020 23:00New Information
Dec-04-2020 13:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For Spontaneous
abortion End Date
& Time
29/Sep/2020 23:00
is before the Start
Date & Time
26/Nov/2020 22:00.
Dec-03-2020 18:17:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-03-2020 18:17:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/29/2020 23:00New Information
Dec-03-2020 12:57:43
(UTC-03:00) City ofACV0PFEINFP6000 Query 1: Reissued:Opened Clinical - SAE
update as of
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866846
Page 161 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires 01Dec20 did not
include a SAE end
date in the Event
section
Dec-03-2020 11:15:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered On 01Dec SAE
safety follow-up
was sent whit this
information. SAE
stop date: 29 NOV
2020
Dec-02-2020 19:12:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL - please
submit a SAE
safety update with
the SAE stop date.
Dec-02-2020 10:28:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/29/2020 23:00New Information
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-16-2020 22:48:08
(UTC-03:00) City ofACV0PFEINFP6000 Query 4: Closed Response satisfies
query
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866847
Page 162 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Buenos Aires
Dec-15-2020 10:52:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Answered SAE report sent on
11DEC says
"Bullet15 is updated
including:
Hospitalization and
Important Medical
event."
Dec-14-2020 16:09:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Reissued:Opened CLINICAL Thank
you. SAE report as
of 11Dec only lists
Medically Important
for the SAE event
Spontaneous
Abortion, although
AE CRF and SAE
narrative states
subject was
admitted; please
update
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866848
Page 163 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-12-2020 11:09:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Answered The event is
considered serious
because it required
hospitalization and
is a medically
important event.
SAE FU Ships
12/11/2020. Thank
you.
Dec-11-2020 12:12:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Reissued:Opened Clinical Thank you;
however AE criteria
for serious includes
HOSP and SAE
report (10Dec20)
does not. Please
harmonize reporting,
and update in the
required location.
Dec-11-2020 11:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Answered SAE report was
updated.
Dec-10-2020 13:17:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Opened CLINICAL -
Serious criteria are
Hospitalization and
Med Important;
however, SAE report
has only Med
Important. Please
review, harmonize
reporting, and
update in the
appropriate location.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866849
Page 164 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-03-2020 16:43:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-03-2020 16:39:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Dec-03-2020 11:11:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered On 01Dec SAE
safety follow-up was
sent with this
information
Dec-03-2020 11:06:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered Covid testing was
not performed
because the AE is
not related to
COVID illness and
the patient did not
present any Covid
symptoms.
Follow-up SAE
form was sent.
Dec-02-2020 19:02:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Opened CLINICAL - Thank
you. Please submit a
SAE safety followup
to also submit the
Hosp criterion for
the SAE.
Dec-02-2020 18:53:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Reissued:Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020442711] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866850
Page 165 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-02-2020 10:27:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Dec-02-2020 10:27:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Dec-02-2020 10:27:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
YESNew Information
Dec-01-2020 17:02:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0866851
Page 166 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Please submit a
follow-up SAE form
[#2020442711] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Dec-01-2020 17:00:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened CLINICAL per SAE
narrative, the event
In Progress Abortion
met another Serious
criterion
(Hospitalization) on
29NOV2020. Please
update the serious
criteria on AE CRF,
and submit a SAE
safety followup with
the same
information.
Dec-01-2020 06:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE In Progress
Abortion: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866852
Page 167 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0866853
Page 168 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-02-2020 18:54:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-02-2020 10:27:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-02-2020 10:27:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Dec-01-2020 16:49:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLINICAL
Concomitant
medication is NO;
however, SAE
report states that
subject received
misoprostol. Please
review, harmonize
reporting, and
update in the
appropriate
location.
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866854
Page 169 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Date Location User Value Reason
Dec-02-2020 10:28:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESNew Information
Nov-29-2020 18:37:47
(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
Dec-04-2020
08:29:37
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Closed outcome updated in SDB
Dec-04-2020
02:48:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Reissued:Op
enedSAE RECON 1: outcome was
reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB, please submit a follow
up AEM form to update outcome in
SDB.
Dec-02-2020
16:10:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Answered Original value is correct
Dec-02-2020
11:08:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE
RECON:AER#2020442711,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form
Dec-02-2020
10:29:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0866855
Page 170 of 172
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Dec-02-2020
10:29:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDNew Information
Dec-02-2020
10:28:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE In progress abortion:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Nov-29-2020
18:37:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-29-2020 18:37:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-01-2020 06:51:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020442711Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866856
Page 171 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020 12:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020 13:23:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-19-2020 13:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-14-2020 12:23:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Aug-19-2020 13:23:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
Aug-19-2020 13:22:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
FDA-CBER-2021-5683-0866857
Page 172 of 172
***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: 12312205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 16:45
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 20:19:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ea8\Final\Final On: 01-Apr-2021 03:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0866858