125742 S1 M5 CRF c4591001 1241 12411766

Document text

Page 1 of 213
***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: 12411766 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996674
Page 2 of 213
***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: 12411766 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/16/2020
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996675
Page 3 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411766]
2.Birth Date: 1985
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996676
Page 4 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996677
Page 5 of 213
***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: 12411766 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
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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996678
Page 6 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996679
Page 7 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996680
Page 8 of 213
***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: 12411766 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996681
Page 9 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996682
Page 10 of 213
***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: 12411766 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:[Allergic rhinitis]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996683
Page 11 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: [81.3]
3.Unit: kg
4.Height: [173.0]
5.Unit: cm
6.Body Mass Index: [27.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996684
Page 12 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996685
Page 13 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [91683]
3.Randomization Group: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996686
Page 14 of 213
***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: 12411766 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/16/2020
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 [BPVZDB]
5.bSample ID [BPVZDC]
5.cSample ID [BPVZDD]
5.dSample ID [BLD1NL]
5.eSample ID [BLD1NM]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996687
Page 15 of 213
***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: 12411766 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/16/2020
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 [BPVZCV]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996688
Page 16 of 213
***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: 12411766 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/16/2020 18:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996689
Page 17 of 213
***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: 12411766 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996690
Page 18 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996691
Page 19 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996692
Page 20 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/9/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996693
Page 21 of 213
***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: 12411766 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/9/2020
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 [BRD3VK]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996694
Page 22 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996695
Page 23 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996696
Page 24 of 213
***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: 12411766 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/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 [BR5TZV]
5.bSample ID [BS2VTZ]
5.cSample ID [BS2VV0]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996697
Page 25 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996698
Page 26 of 213
***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: 12411766 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 [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996699
Page 27 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996700
Page 28 of 213
***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: 12411766 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 [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996701
Page 29 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996702
Page 30 of 213
***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: 12411766 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 [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996703
Page 31 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996704
Page 32 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/20/2020
2.Date of First Symptom Started: Nov/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/21/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996705
Page 33 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996706
Page 34 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/21/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996707
Page 35 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/21/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ROCHE MOLECULAR SYSTEMS COBAS SARS-COV-2
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996708
Page 36 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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_SELF
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
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 [RW90952]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996709
Page 37 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject used self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996710
Page 38 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996711
Page 39 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996712
Page 40 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996713
Page 41 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Gastroenteritis]
Date of Diagnosis:
Dec/23/2020
3.Toxicity Grade: 1
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996714
Page 42 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996715
Page 43 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996716
Page 44 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996717
Page 45 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996718
Page 46 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996719
Page 47 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996720
Page 48 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996721
Page 49 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996722
Page 50 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996723
Page 51 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996724
Page 52 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996725
Page 53 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996726
Page 54 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996727
Page 55 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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.Start Date: //
6.Ongoing?
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996728
Page 56 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996729
Page 57 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996730
Page 58 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/23/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996731
Page 59 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/23/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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:
Dec/23/2020
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 [BR796N]
5.bSample ID [BS2JTK]
5.cSample ID [BS2JTL]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996732
Page 60 of 213
***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: 12411766 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:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996733
Page 61 of 213
***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: 12411766 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 [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996734
Page 62 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996735
Page 63 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996736
Page 64 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Maternal exposure during
pregnancy Sep/17/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996737
Page 65 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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)[Maternal exposure during pregnancy]
4.Start Date Time: Sep/17/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pregnancy]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996738
Page 66 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996739
Page 67 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996740
Page 68 of 213
***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: 12411766 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[ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996741
Page 69 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996742
Page 70 of 213
***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: 12411766 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: //
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996743
Page 71 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996744
Page 72 of 213
***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: 12411766 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?
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996745
Page 73 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996746
Page 74 of 213
***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: 12411766 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?
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996747
Page 75 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996748
Page 76 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996749
Page 77 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/9/2020
2.Phase of Disposition: VACCINATION
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996750
Page 78 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996751
Page 79 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 12411766 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:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996752
Page 80 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996753
Page 81 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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?
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996754
Page 82 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996755
Page 83 of 213
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996756
Page 84 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996757
Page 85 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996758
Page 86 of 213
***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: 12411766 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 [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996759
Page 87 of 213
***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: 12411766 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 [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996760
Page 88 of 213
***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: 12411766 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: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996761
Page 89 of 213
***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: 12411766 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996762
Page 90 of 213
***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: 12411766 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996763
Page 91 of 213
***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: 12411766 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996764
Page 92 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996765
Page 93 of 213
***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: 12411766 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: [ ]
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996766
Page 94 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/9/2020
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996767
Page 95 of 213
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996768
Page 96 of 213
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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
Edson Moreira  Approved Mar-08-2021 13:56:11 (UTC-03:00) City of
Buenos AiresBOOK Signed
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.
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996769
Page 97 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996770
Page 98 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996771
Page 99 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996772
Page 100 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996773
Page 101 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996774
Page 102 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996775
Page 103 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996776
Page 104 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
7Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996777
Page 105 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
8Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996778
Page 106 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
9Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996779
Page 107 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
10Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996780
Page 108 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
11Oct-13-2020 08:25:09 (UTC-03:00) City of
Buenos AiresSubject is pregnant
Not Done
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996781
Page 109 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Nov-04-2020 12:06:51 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0996782
Page 110 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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
Edson Moreira  Approved Mar-08-2021 13:56:11 (UTC-03:00) City of
Buenos AiresBOOK Signed
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.
 N/A Mar-04-2021 10:39:43 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira  Approved Feb-15-2021 12:05:07 (UTC-03:00) City of
Buenos AiresBOOK Signed
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.
 N/A Feb-09-2021 08:52:45 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996783
Page 111 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 Approved Feb-04-2021 23:54:08 (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 08:58:48 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira  Approved Jan-22-2021 05:57:34 (UTC-03:00) City of
Buenos AiresBOOK Signed
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.
 N/A Nov-23-2020 10:24:36 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-08-2020 08:44:31 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996784
Page 112 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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.
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996785
Page 113 of 213
***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: 12411766 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-16-2020 21:17:03
(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-16-2020 21:17:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996786
Page 114 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020 21:17:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/16/2020Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996787
Page 115 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020 21:16:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12411766Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020 21:16:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020 21:17:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020 21:17:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-16-2020 21:17:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996788
Page 116 of 213
***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: 12411766 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-16-2020 21:17:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996789
Page 117 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65
and 85 years, inclusive, or
18 and 85 years, inclusive
, at randomization (depen
dent upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, inc
lusive, 65 and 85 years, inclusive,
or 18 and 85 years, inclusive, at ra
ndomization (dependent upon studInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996790
Page 118 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
y stage)
1.a Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vac
cination plan, laboratory t
ests, lifestyle consideratio
ns, and other study proce
dures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996791
Page 119 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and a
ble to comply with all scheduled vi
sits, vaccination plan, laboratory te
sts, lifestyle considerations, and ot
her study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996792
Page 120 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996793
Page 121 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgmen
t of the investigator to be eligible f
or inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996794
Page 122 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requiremen
ts and restrictions listed i
n the ICD and in this prot
ocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996795
Page 123 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996796
Page 124 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condi
tion incl. recent (within past year)
or active suicidal ideation/behavio
r/lab abnormality that may increas
e the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996797
Page 125 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996798
Page 126 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatit
is C virus (HCV), or hepatitis B vi
rus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component o
f the study intervention(s)Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996799
Page 127 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reaction
associated with a vaccine and/or se
vere allergic reaction (eg, anaphyla
xis) to any component of the study
intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996800
Page 128 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996801
Page 129 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996802
Page 130 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examin
ationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996803
Page 131 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that wou
ld, in the opinion of the i
nvestigator, contraindicat
e intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996804
Page 132 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding th
at would, in the opinion of the inve
stigator, contraindicate intramuscu
lar injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeeding
Criterion met
?:NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996805
Page 133 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or breast
feedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any coron
avirus vaccineInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996806
Page 134 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996807
Page 135 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic corti
costeroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosupp
ressive therapy, such as cytotoxic a
gents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996808
Page 136 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admini
stration or planned receip
t throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996809
Page 137 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention administ
ration or planned receipt througho
ut the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996810
Page 138 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:16
Criteri
on Desc
ription:Participation in other st
udies involving study in
tervention within 28 day
s prior to study entry an
d/or during study partici
pation
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996811
Page 139 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies invol
ving study intervention within 28
days prior to study entry and/or du
ring study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:17
Criterion
Descripti
on:Previous participation
in other studies involvi
ng study intervention c
ontaining lipid nanopa
rticlesInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996812
Page 140 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other stu
dies involving study intervention c
ontaining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(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-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu22Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996813
Page 141 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
sion N
umbe
r:
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff other
wise supervised by the in
vestigator, and their respe
ctive family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996814
Page 142 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer em
ployees directly involved in the co
nduct of the study, site staff other
wise supervised by the investigato
r, and their respective family mem
bersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-16-2020 21:18:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996815
Page 143 of 213
***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: 12411766 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-16-2020 21:18:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 21:18:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020 21:18:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996816
Page 144 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 21:19:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Allergic rhinit
is
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 21:19:06
(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
Sep-16-2020 21:19:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Allergic rhinitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 21:19:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 21:19:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996817
Page 145 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
81.3Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
173.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.2Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996818
Page 146 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 21:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996819
Page 147 of 213
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996820
Page 148 of 213
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020 21:19:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996821
Page 149 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020 21:19:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020 21:19:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
91683Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996822
Page 150 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 07:35:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 07:35:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 07:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 07:35:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 07:35:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 07:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVZDBInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996823
Page 151 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 07:35:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVZDBInitial Entry
5.b
Date Location User Value Reason
Sep-17-2020 07:35:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVZDCInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 07:35:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVZDCInitial Entry
5.c
Date Location User Value Reason
Sep-17-2020 07:35:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVZDDInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 07:35:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVZDDInitial Entry
5.d
Date Location User Value Reason
Sep-17-2020 07:35:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD1NLInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996824
Page 152 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.d Sample ID
Date Location User Value Reason
Sep-17-2020 07:35:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLD1NLInitial Entry
5.e
Date Location User Value Reason
Sep-17-2020 07:35:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLD1NMInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-17-2020 07:35:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLD1NMInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996825
Page 153 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 07:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 07:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 07:36:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 07:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 07:36:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 07:36:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVZCVInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996826
Page 154 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 07:36:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVZCVInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996827
Page 155 of 213
***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: 12411766 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-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020 18:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996828
Page 156 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7. Route:
Date Location User Value Reason
Sep-16-2020 21:20:22
(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-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-16-2020 21:20:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996829
Page 157 of 213
***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: 12411766 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-16-2020 21:20:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996830
Page 158 of 213
***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: 12411766 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-13-2020 08:24:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996831
Page 159 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-13-2020 08:24:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2.a
Date Location User Value Reason
Oct-13-2020 08:24:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-13-2020 08:24:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-13-2020 08:24:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-13-2020 08:24:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996832
Page 160 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-13-2020 08:24:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996833
Page 161 of 213
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996834
Page 162 of 213
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: POSITIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-14-2020 01:56:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-13-2020 08:58:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Subjectnwas not
vaccinated
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Lab result is
“Positive”, but
subject has been
vaccinated. Please
review and update
as appropriate. Else
explain.
Oct-13-2020 08:24:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996835
Page 163 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 08:57:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 08:57:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 08:57:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 08:57:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-13-2020 08:57:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 08:57:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRD3VKInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996836
Page 164 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 08:57:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRD3VKInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996837
Page 165 of 213
***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: 12411766 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-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996838
Page 166 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7. Route:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-13-2020 08:25:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996839
Page 167 of 213
***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: 12411766 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-06-2020 15:45:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996840
Page 168 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 16:03:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 16:03:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 16:03:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 16:03:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-06-2020 16:03:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
Nov-06-2020 16:03:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR5TZVInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996841
Page 169 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 16:03:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR5TZVInitial Entry
5.b
Date Location User Value Reason
Nov-06-2020 16:03:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2VTZInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020 16:03:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2VTZInitial Entry
5.c
Date Location User Value Reason
Nov-06-2020 16:04:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2VV0Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020 16:04:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2VV0Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996842
Page 170 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12411766 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-23-2020 10:25:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-23-2020 10:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-23-2020 10:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Nov-23-2020 10:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-23-2020 10:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996843
Page 171 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-23-2020 10:06:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved
:
Nov/21/2020New Information
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996844
Page 172 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
4.a Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996845
Page 173 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.c Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996846
Page 174 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996847
Page 175 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996848
Page 176 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.i
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-23-2020 10:25:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996849
Page 177 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996850
Page 178 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/21/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ROCHE MOLECULAR SYSTE
MS COBAS SARS-COV-2Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996851
Page 179 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7. Test Result:
Date Location User Value Reason
Nov-25-2020 08:41:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996852
Page 180 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 10:25:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 10:25:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 10:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 10:25:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-23-2020 10:25:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020 10:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: RW90952Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996853
Page 181 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 10:25:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RW90952Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996854
Page 182 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 10:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 10:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 10:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-23-2020 10:26:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subject used self swabInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996855
Page 183 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996856
Page 184 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996857
Page 185 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996858
Page 186 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-23-2020 10:26:25
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996859
Page 187 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996860
Page 188 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/20/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-23-2020 10:26:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Dec-23-2020 10:06:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
Gastroenteritis
Date of Diagnosis:
Dec/23/2020New Information
Nov-23-2020 10:26:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-23-2020 10:26:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996861
Page 189 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/23/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020 10:06:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/23/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-23-2020 10:06:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996862
Page 190 of 213
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/23/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 11:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 11:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-23-2020 11:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-23-2020 11:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-23-2020 11:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/23/2020Initial Entry
5.a
Date Location User Value Reason
Dec-23-2020 11:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR796NInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996863
Page 191 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/23/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Dec-23-2020 11:08:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR796NInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020 11:08:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2JTKInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-23-2020 11:08:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2JTKInitial Entry
5.c
Date Location User Value Reason
Dec-23-2020 11:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2JTLInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-23-2020 11:08:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2JTLInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996864
Page 192 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996865
Page 193 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-04-2020 09:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Maternal exposure during p
regnancyTranscription Error
Nov-04-2020 08:05:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed SAE RECON 1:Term
updated in CRF however,
please confirm if a follow
up AEM form was
submitted to update term in
Safety database.
Nov-03-2020 13:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-03-2020 13:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exposure during pregnancyTranscription Error
Nov-03-2020 10:51:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020394345,
the term in both database
was recorded as pregnancy.
Based on the latest EDP
guidance,the term should be
reported as 'EXPOSURE
DURING PREGNANCY'.
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996866
Page 194 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Please confirm and
update.A follow up AEM
form is required to update
SDB.
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-04-2021 10:39:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/17/2020 UNK:UNKNew Information
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020 12:06:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Nov-04-2020 12:06:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Oct-13-2020 08:29:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996867
Page 195 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 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-05-2020 00:42:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed seriousness downgraded
to No. issue resolved
Nov-04-2020 09:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Nov-04-2020 09:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Nov-04-2020 09:48:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOTranscription Error
Nov-04-2020 09:47:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened 'Is the adverse event
serious?' is marked as
YES, but responses to all
of the seriousness criteria
are NO. At least one
seriousness criterion is
expected to be YES for
serious events. Please
review and update as
appropriate.
Nov-04-2020 09:47:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?Transcription Error
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996868
Page 196 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NO
Nov-04-2020 09:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate For AE Maternal
exposure during
pregnancy: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Nov-04-2020 08:09:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Deleted Query can be addressed
internally
Nov-03-2020 13:34:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE Exposure during
pregnancy: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Oct-30-2020 10:10:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered According to protocol
item 8.3.5.1 PA#6
Oct-29-2020 16:50:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Clinical_ Please elaborate
on how this event is
considered an important
medical event. Thank
you.
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996869
Page 197 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-29-2020 08:58:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Candidate for clinical review
Oct-27-2020 16:10:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered According to PI This is a
medically important
event
Oct-21-2020 07:09:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1:Thank
you for your response.
Could you please
elaborate on how this
event met seriousness
criteria?
Oct-20-2020 17:41:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered PI considered medically
important serious event
Oct-16-2020 07:12:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1: Per
Clinical review, The
pregnancy was
appropriately reported to
safety; however,
seriousness criteria is met
only if there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria
accordingly.
Oct-15-2020 14:40:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered SAE was reported to
Safety database
Oct-14-2020 08:04:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:pregnancy(Onset
date:09Oct2020) is not
reported to Safety
database but marked
serious on AE
CRF.Confirm seriousness
and report to Pfizer
immediately.If this event
is not serious, downgrade
the event on AE CRF
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996870
Page 198 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Pregnancy:
Response to "Is the
adverse event serious?" is
'Yes' but "Serious
Adverse Event Number"
is blank.
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
YESInitial 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
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996871
Page 199 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-07-2020
09:54:40
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Sandip Namdeorao
SuryawanshiQuery 1: Cl
osedResponse
satisfies query
Nov-05-2020
14:26:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: A
nsweredno update as
necessary
Nov-05-2020
08:47:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: O
penedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in the
comment field
[Pregnancy].
Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. Please
review and
update as
necessary.
Oct-13-2020
08:28:20
(UTC-03:00)
City of BuenosACV0PFEINFP6000  Data Entr
y:
NOT REL
ATEDInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4)
FDA-CBER-2021-5683-0996872
Page 200 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aires If Not Rel
ated to st
udy treat
ment(s), t
his event
is due to:
OTHER
If Othe
r, speci
fy:
Preg
nanc
y
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020
12:08:28
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
DRUG
WITHD
RAWNTranscription Error
Oct-20-2020
11:30:35
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2:
ClosedAuto closed by
Validation Check:
VC_AE001_32
Oct-20-2020
07:11:29
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2:
Answere
dTranscription Error
Oct-20-2020
07:11:29
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
NOT AP
PLICAB
LETranscription Error
Oct-16-2020
03:24:01
(UTC-03:00)
City ofACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2:
OpenedDMW5004151;The
Latest Action to
Study Treatment is
DRUG
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996873
Page 201 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires WITHDRAWN,
but the Disposition-
Treatment Form
Status is not
DEATH OR
ADVERSE
EVENT. Please
review and update
as appropriate.
Oct-15-2020
16:48:24
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1:
ClosedResponse satisfies
query
Oct-15-2020
14:41:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1:
Answere
dTranscription Error
Oct-15-2020
14:41:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
DRUG
WITHD
RAWNTranscription Error
Oct-14-2020
09:52:54
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Hayley Wyper Query 1:
OpenedCLINQUERY:
Please review
entry: Vaccination
2 has not been
given per CRF
Oct-13-2020
08:28:20
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
NOT AP
PLICAB
LEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996874
Page 202 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020 08:28:20
(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-06-2020 02:15:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Nov-05-2020 16:55:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Answered According with
Updated CRF CG are
forthcoming with the
following update to
8.50.2.5 Specific
Guidance for
Pregnancy the
outcome is
UNKNOWN.
Nov-05-2020 14:54:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Reissued:Opened DM: If AE is still
ongoing, Please
consider to provide an
outcome to adverse
event that's
appropriate, or else
clarify.
Nov-04-2020 12:12:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Answered Original value is
correct
Nov-04-2020 12:07:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened For AE Maternal
exposure during
pregnancy: Response
to "What was the
outcome of this
adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996875
Page 203 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
event still ongoing?"
is marked "Yes".
Nov-04-2020 12:07:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNKNOWNTranscription Error
Nov-04-2020 09:47:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-04-2020 09:47:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDTranscription Error
Nov-04-2020 09:46:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened For AE Maternal
exposure during
pregnancy: Response
to "What was the
outcome of this
adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-04-2020 08:32:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 08:25:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened For AE Exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-04-2020 08:25:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-04-2020 08:25:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNKNOWNTranscription Error
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996876
Page 204 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-04-2020 08:06:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1:
.Based on the latest
EDP guidance,
outcome should be
recorded as
UNKNOWN. Please
confirm and update
accordingly.
Nov-03-2020 14:52:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-03-2020 14:52:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGTranscription Error
Nov-03-2020 13:35:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Nov-03-2020 13:35:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-03-2020 13:35:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNKNOWNTranscription Error
Nov-03-2020 10:52:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020394345,
the outcome in AE
CRF was reported as
NOT
RECOVERED/NOT
RESOLVED.Based
on the latest EDP
guidance, outcome
should be recorded as
UNKNOWN. Please
confirm and update
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996877
Page 205 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
accordingly.
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020 08:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996878
Page 206 of 213
***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: 12411766 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
Oct-13-2020 08:25:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 08:25:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020 08:48:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-28-2020 09:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Answer Auto Query
Oct-16-2020 11:04:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened DM: "Specify
Status" (item4) is not
required if Status is
"PREGNANCY" at
(item 3). Please
review and update
accordingly.
Oct-15-2020 17:14:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered data updated
Oct-15-2020 17:13:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "Status"
is PREGNANCY but
"Specify Status" is
Provided.
Oct-13-2020 08:25:44
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
PREGNANCYInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996879
Page 207 of 213
***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: 12411766 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
4. Specify Status:
Date Location User Value Reason
Oct-28-2020 09:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry: Transcription Error
Oct-15-2020 17:13:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Discontinued
Vaccination 2 not administeredTranscription Error
Oct-15-2020 17:13:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Vaccination 2 not administeredInitial Entry
090177e196ae3f4a\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996880
Page 208 of 213
***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: 12411766 Subject Initials: ---
…[truncated]