Document text
Page 1 of 188
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997254
Page 2 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/17/2020
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997255
Page 3 of 188
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411862]
2.Birth Date: 1974
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0997256
Page 4 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997257
Page 5 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997258
Page 6 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
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
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997259
Page 7 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997260
Page 8 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997261
Page 9 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997262
Page 10 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997263
Page 11 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997264
Page 12 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Asthma]
Start Date: UNK/UNK/1981
Ongoing: NO
End Date:
UNK/UNK/1990
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergic rhinitis]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/UNK/2020
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997265
Page 13 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
2.Weight: [98.7]
3.Unit: kg
4.Height: [182.0]
5.Unit: cm
6.Body Mass Index: [29.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997266
Page 14 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/17/2020
2.Randomization Number: [93099]
3.Randomization Group: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997267
Page 15 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BPWY0K]
5.bSample ID [BPWY0L]
5.cSample ID [BPWY0M]
5.dSample ID [BRTCSL]
5.eSample ID [BRTCSM]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997268
Page 16 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BPWX68]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997269
Page 17 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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/17/2020 20:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997270
Page 18 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997271
Page 19 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997272
Page 20 of 188
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997273
Page 21 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVY9V]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997274
Page 22 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: Oct/6/2020 09:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997275
Page 23 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997276
Page 24 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
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 [BR79GV]
5.bSample ID [BS7TNR]
5.cSample ID [BS7TNS]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997277
Page 25 of 188
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997278
Page 26 of 188
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997279
Page 27 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997280
Page 28 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997281
Page 29 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997282
Page 30 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997283
Page 31 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997284
Page 32 of 188
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997285
Page 33 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997286
Page 34 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997287
Page 35 of 188
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997288
Page 36 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997289
Page 37 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997290
Page 38 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997291
Page 39 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997292
Page 40 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997293
Page 41 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997294
Page 42 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997295
Page 43 of 188
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
1.ADVERS
E EVENT
1 Injection site pain Sep/18/202
0 UNK:UN
K NO
End Date Time:
Sep/20/2020 U
NK:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 Injection site pain Oct/6/2020
23:00 NO
End Date Time:
Oct/9/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT
3 Axillary lymph nodes
enlargement in left ar
m Oct/6/2020
23:00 NO
End Date Time:
Oct/9/2020 UN
K:UNK
Repeating
Pages
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997296
Page 44 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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)[Injection site pain]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997297
Page 45 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997298
Page 46 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997299
Page 47 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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)[Injection site pain]
4.Start Date Time: Oct/6/2020 23:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997300
Page 48 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997301
Page 49 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997302
Page 50 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Axillary lymph nodes enlargement in left arm]
4.Start Date Time: Oct/6/2020 23:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997303
Page 51 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997304
Page 52 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997305
Page 53 of 188
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997306
Page 54 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997307
Page 55 of 188
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997308
Page 56 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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: //
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997309
Page 57 of 188
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997310
Page 58 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997311
Page 59 of 188
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997312
Page 60 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997313
Page 61 of 188
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997314
Page 62 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997315
Page 63 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997316
Page 64 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997317
Page 65 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997318
Page 66 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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?
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997319
Page 67 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997320
Page 68 of 188
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997321
Page 69 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997322
Page 70 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997323
Page 71 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997324
Page 72 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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 [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997325
Page 73 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997326
Page 74 of 188
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997327
Page 75 of 188
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997328
Page 76 of 188
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997329
Page 77 of 188
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997330
Page 78 of 188
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997331
Page 79 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997332
Page 80 of 188
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997333
Page 81 of 188
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Feb-05-2021 01:28:13 (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.
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0997334
Page 82 of 188
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Feb-05-2021 01:28:13 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-03-2021 09:49:41 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Nov-10-2020 09:47:53 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0997335
Page 83 of 188
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, EdsonMoreira, 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.
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997336
Page 84 of 188
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-17-2020
21:04:54
(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
Sep-17-2020
21:04:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997337
Page 85 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020
21:05:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/17/2020Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997338
Page 86 of 188
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020
21:04:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12411862Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020
21:04:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1974Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020
21:05:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-17-2020
21:05:22
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OFInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997339
Page 87 of 188
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020
21:05:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997340
Page 88 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020
21:05:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997341
Page 89 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or female
participants bet
ween the ages
of 18 and 55 ye
ars, inclusive, 6
5 and 85 years,
inclusive, or 18
and 85 years, in
clusive, at rand
omization (dep
endent upon stu
dy stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997342
Page 90 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female partic
ipants between the ag
es of 18 and 55 years,
inclusive, 65 and 85 y
ears, inclusive, or 18
and 85 years, inclusiv
e, at randomization (d
ependent upon study
stage)Initial Entry
1.a Criterion met?
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997343
Page 91 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997344
Page 92 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing a
nd able to com
ply with all sch
eduled visits, v
accination plan
, laboratory tes
ts, lifestyle con
siderations, an
d other study p
rocedures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997345
Page 93 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997346
Page 94 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are
determined by
medical history
, physical exa
mination, and c
linical judgme
nt of the invest
igator to be eli
gible for inclus
ion in the study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997347
Page 95 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997348
Page 96 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants
who are determined b
y medical history, ph
ysical examination, a
nd clinical judgment
of the investigator to
be eligible for inclusi
on in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997349
Page 97 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n De
scri
ptio
n:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the r
equirements an
d restrictions li
sted in the ICD
and in this prot
ocol
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997350
Page 98 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997351
Page 99 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving per
sonal signed informe
d consent, which incl
udes compliance with
the requirements and
restrictions listed in t
he ICD and in this pr
otocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997352
Page 100 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. r
ecent (within p
ast year) or acti
ve suicidal idea
tion/behavior/l
ab abnormality
that may increa
se the risk of st
udy participati
on
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997353
Page 101 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past ye
ar) or active suicidal i
deation/behavior/lab
abnormality that may
increase the risk of st
udy participationInitial Entry
2.a Criterion met?
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997354
Page 102 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usion
Num
ber:2
Crite
rion
Desc
riptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997355
Page 103 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crite
rion
met?
:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997356
Page 104 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997357
Page 105 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
2.c
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of seve
re adverse reac
tion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylaxi
s) to any comp
onent of the st
udy interventio
n(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997358
Page 106 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997359
Page 107 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adv
erse reaction associat
ed with a vaccine and
/or severe allergic rea
ction (eg, anaphylaxis
) to any component of
the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997360
Page 108 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descr
iption:Receipt of
medication
s intended t
o prevent C
OVID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997361
Page 109 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.d Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997362
Page 110 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with kno
wn or suspecte
d immunodefic
iency, as deter
mined by histo
ry and/or labor
atory/physical
examination
Crit
erio
n me
t?:NO
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997363
Page 111 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised
individuals with kno
wn or suspected imm
unodeficiency, as dete
rmined by history and
/or laboratory/physica
l examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997364
Page 112 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scri
ptio
n:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inve
stigator, contra
indicate intram
uscular injectio
n
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997365
Page 113 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997366
Page 114 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the
opinion of the investi
gator, contraindicate i
ntramuscular injectio
nInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997367
Page 115 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or b
reastfeedi
ng
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX11A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997368
Page 116 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997369
Page 117 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX12A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997370
Page 118 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997371
Page 119 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997372
Page 120 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemic
corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997373
Page 121 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
2.j
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of blo
od/plasma pro
ducts or immu
noglobulin, fro
m 60 days bef
ore study inter
vention admini
stration or plan
ned receipt thr
oughout the st
udy
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997374
Page 122 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX14A01
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997375
Page 123 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997376
Page 124 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997377
Page 125 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studie
s involving st
udy interventi
on within 28
days prior to s
tudy entry and
/or during stu
dy participati
on
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997378
Page 126 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997379
Page 127 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
2.l
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous part
icipation in o
ther studies i
nvolving stud
y interventio
n containing
lipid nanopar
ticles
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997380
Page 128 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.l Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997381
Page 129 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
2.m
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n N
um
ber:22
Crit
erio
n D
escr
ipti
on:Investigator sit
e staff or Pfize
r employees di
rectly involved
in the conduct
of the study, sit
e staff otherwis
e supervised b
y the investigat
or, and their re
spective family
members
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997382
Page 130 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX21A01
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997383
Page 131 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff
or Pfizer employees
directly involved in t
he conduct of the stu
dy, site staff otherwis
e supervised by the i
nvestigator, and their
respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997384
Page 132 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-17-2020
21:06:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997385
Page 133 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-17-2020
21:06:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020
21:06:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020
21:06:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997386
Page 134 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020
21:07:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Asthma
Start Date
:UNK/UN
K/1981
Ongoing: NO
End Date
:
UNK/U
NK/199
0Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020
21:07:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997387
Page 135 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-17-2020
21:07:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-17-2020
21:07:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1981Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020
21:07:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.b
Date Location User Value Reason
Sep-17-2020
21:08:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Allergic rh
initisInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997388
Page 136 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Start Date
:Mar/UNK/
2020
Ongoing: NO
End Date
:
Mar/U
NK/20
20
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997389
Page 137 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020
21:08:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
21:08:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Allergic rhinitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020
21:08:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-17-2020
21:08:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
Mar/UNK/2020Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997390
Page 138 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
98.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-17-2020
21:09:06ACV0PFEINFP6000 Data Entry:
182.0Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997391
Page 139 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Unit:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.8Initial Entry
7.a
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.1
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997392
Page 140 of 188
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
21:09:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997393
Page 141 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-17-2020
21:09:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-17-2020
21:09:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
93099Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997394
Page 142 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
07:44:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
07:44:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
07:44:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
07:44:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997395
Page 143 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Sep-18-2020
07:44:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
07:44:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWY0
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
07:44:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWY0KInitial Entry
5.b
Date Location User Value Reason
Sep-18-2020
07:44:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWY0
LInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997396
Page 144 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Sep-18-2020
07:44:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWY0LInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020
07:44:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPWY0
MInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-18-2020
07:44:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWY0MInitial Entry
5.d
Date Location User Value Reason
Sep-18-2020
07:44:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BRTCS
LInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997397
Page 145 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.d Sample ID
Date Location User Value Reason
Sep-18-2020
07:44:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRTCSLInitial Entry
5.e
Date Location User Value Reason
Sep-18-2020
07:44:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BRTCS
MInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-18-2020
07:44:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BRTCSMInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997398
Page 146 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
07:45:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
07:45:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
07:45:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
07:45:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997399
Page 147 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Sep-18-2020
07:45:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
07:45:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPWX6
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
07:45:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPWX68Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997400
Page 148 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Sep/17/2020 20:23Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997401
Page 149 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
21:09:47
(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-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997402
Page 150 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-17-2020
21:09:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997403
Page 151 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-17-2020
21:09:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997404
Page 152 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
11:58:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997405
Page 153 of 188
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020
11:58:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020
11:58:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.4
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020
11:58:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997406
Page 154 of 188
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Oct-06-2020
11:58:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020
11:58:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-06-2020
11:58:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997407
Page 155 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020
07:24:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020
07:24:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020
07:24:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-07-2020
07:24:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997408
Page 156 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-07-2020
07:24:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020
07:24:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BPVY9
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020
07:24:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPVY9VInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997409
Page 157 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Oct/6/2020 09:42Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997410
Page 158 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997411
Page 159 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-06-2020
11:59:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997412
Page 160 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020
13:59:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997413
Page 161 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020
16:30:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020
16:30:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020
16:30:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-03-2020
16:30:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997414
Page 162 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Nov-03-2020
16:30:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020
16:30:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BR79G
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020
16:30:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BR79GVInitial Entry
5.b
Date Location User Value Reason
Nov-03-2020
16:30:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BS7TN
RInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997415
Page 163 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Nov-03-2020
16:30:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS7TNRInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020
16:30:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BS7TN
SInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020
16:30:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BS7TNSInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997416
Page 164 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997417
Page 165 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997418
Page 166 of 188
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997419
Page 167 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-06-2020
12:00:15ACV0PFEINFP6000 Data Entry:
Sep/18/2020 UNK:UInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997420
Page 168 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos AiresNK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/20/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-06-2020
12:00:15
(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
Oct-06-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0997421
Page 169 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
12:00:15
(UTC-03:00) City
of Buenos AiresNO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997422
Page 170 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-06-2020
12:00:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0997423
Page 171 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020
15:02:39
(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 Value Reason
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-03-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997424
Page 172 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
15:02:39
(UTC-03:00) City
of Buenos AiresOct/6/2020 23:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020
15:05:33
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/9/2020 U
NK:UNKTranscription
Error
Nov-03-2020
15:02:39
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/8/2020 U
NK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997425
Page 173 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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-03-2020
15:02:39
(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-03-2020
15:02:39
(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-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997426
Page 174 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020
15:02:39
(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
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997427
Page 175 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-03-2020
15:02:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997428
Page 176 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-05-2020
15:51:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-05-2020
07:36:06
(UTC-03:00)
City of BuenosACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edTranscription
Error
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997429
Page 177 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aires
Nov-05-2020
07:36:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Axillary lymph n
odes enlargement
in left armTranscription
Error
Nov-04-2020
17:02:17
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Reissue
d:OpenedCLINQUERY-
please confirm
if you mean
"axillary"
lymph nodes
enlargement in
left arm? thank
you
Nov-04-2020
11:14:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edTranscription
Error
Nov-04-2020
11:14:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Lymph node enla
rgement in left ar
mTranscription
Error
Nov-04-2020
10:23:19
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened CLINQUERY-
Please specify
the anatomical
location of
lymph nodes
involved and
whether
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997430
Page 178 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
bilateral, left or
right Thank you
Nov-03-2020
15:04:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Lymph node enla
rgementInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/6/2020 23:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/9/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997431
Page 179 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
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-03-2020
15:04:58
(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-03-2020
15:04:58
(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-03-2020
15:04:58
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997432
Page 180 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020
15:04:58
(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
Nov-03-2020
15:04:58
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997433
Page 181 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-03-2020
15:04:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997434
Page 182 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-03-2020
14:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020
14:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020
14:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997435
Page 183 of 188
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
09:50:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997436
Page 184 of 188
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021
09:50:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible and NO
T confirmed to h
ave received onl
y placebo at Vac
cination 1/2Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997437
Page 185 of 188
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021
09:49:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021
09:49:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0997438
Page 186 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-03-2020
14:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-17-2020
21:09:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-17-2020
21:06:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-03-2020
14:00:00
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/3/2020Initial Entry
Sep-17-2020
21:09:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/17/2020Initial Entry
Sep-17-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0997439
Page 187 of 188
***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: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
21:06:08
(UTC-03:00) City
of Buenos Aires(autocalc) Sep/17/2020
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FDA-CBER-2021-5683-0997440
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***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411862 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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1. Casebook Signature
Date Location User Value Reason
Nov-10-2020
09:47:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Edson
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090177e196ae3f76\Final\Final On: 01-Apr-2021 05:16 (GMT)
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FDA-CBER-2021-5683-0997441