125742 S1 M5 CRF c4591001 1241 12411561

Document text

Page 1 of 299
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995770
Page 2 of 299
***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: 12411561 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/2/2020
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995771
Page 3 of 299
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411561]
2.Birth Date: 1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995772
Page 4 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995773
Page 5 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995774
Page 6 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995775
Page 7 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995776
Page 8 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995777
Page 9 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995778
Page 10 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995779
Page 11 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995780
Page 12 of 299
***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: 12411561 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:[Hemorrhoidectomy]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Menopause]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995781
Page 13 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Lower Limb Varicose Veins]
Start Date: May/UNK/2020
Ongoing: YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995782
Page 14 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [76.5]
3.Unit: kg
4.Height: [164.0]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995783
Page 15 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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/2/2020
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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995784
Page 16 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [78945]
3.Randomization Group: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995785
Page 17 of 299
***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: 12411561 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/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWX8K]
5.bSample ID [BPWX8L]
5.cSample ID [BPWX8M]
5.dSample ID [BLCTR6]
5.eSample ID [BLCTR7]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995786
Page 18 of 299
***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: 12411561 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/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWXBG]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995787
Page 19 of 299
***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: 12411561 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/2/2020 18:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995788
Page 20 of 299
***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: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995789
Page 21 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995790
Page 22 of 299
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995791
Page 23 of 299
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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/22/2020
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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995792
Page 24 of 299
***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: 12411561 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/22/2020
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 [BPVYD8]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995793
Page 25 of 299
***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: 12411561 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/22/2020 14:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995794
Page 26 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995795
Page 27 of 299
***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: 12411561 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:
Oct/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 [BR74FF]
5.bSample ID [BS5CC8]
5.cSample ID [BS5CC9]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995796
Page 28 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995797
Page 29 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/24/2020
2.Date of First Symptom
Started:Dec/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/27/2020
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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995798
Page 30 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Runny nose]
5.bSymptoms - Other Text: [Sneeze]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995799
Page 31 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Dec/26/
2020 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995800
Page 32 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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: Dec/26/2020
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: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995801
Page 33 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 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:
Dec/24/2020
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 [RW92829]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995802
Page 34 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 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 [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995803
Page 35 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995804
Page 36 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995805
Page 37 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995806
Page 38 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995807
Page 39 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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?NO
3.Toxicity Grade: 1
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995808
Page 40 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995809
Page 41 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995810
Page 42 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995811
Page 43 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995812
Page 44 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995813
Page 45 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995814
Page 46 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995815
Page 47 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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:[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995816
Page 48 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995817
Page 49 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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 % [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995818
Page 50 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995819
Page 51 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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):[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995820
Page 52 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995821
Page 53 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 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?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995822
Page 54 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995823
Page 55 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995824
Page 56 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/21/2021Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995825
Page 57 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/21/2021Form: 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: 12411561 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:
Jan/21/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTKP3]
5.bSample ID [BRT74X]
5.cSample ID [BRT74Y]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995826
Page 58 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995827
Page 59 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995828
Page 60 of 299
***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: 12411561 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/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995829
Page 61 of 299
***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: 12411561 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: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995830
Page 62 of 299
***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: 12411561 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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995831
Page 63 of 299
***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: 12411561 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 [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995832
Page 64 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yAE Id
entifie
rAdverse Eve
ntStart DateIs the Adverse E
vent Still Ongoi
ngForm Insta
nce
 1. ADVER
SE EVE
NT 1 Diarrhea  Sep/25/202
0 UNK:U
NK NO
End Date Time:
Sep/30/2020
UNK:UNK
 Repeating
Pages
 2. ADVER
SE EVE
NT 2 Fever  Sep/26/202
0 UNK:U
NK NO
End Date Time:
Sep/26/2020
UNK:UNK
 Repeating
Pages
 3. DELETED ADVER
SE EVE
NT 3 Varicose vein
s in lower li
mbs Oct/1/2020
UNK:UN
K YES  Repeating
Pages
 4. ADVER
SE EVE
NT 4 Injection site
pain Feb/1/2021
18:00 NO
End Date Time:
Feb/5/2021 U
NK:UNK
 Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995833
Page 65 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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)[Diarrhea]
4.Start Date Time: Sep/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/30/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995834
Page 66 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995835
Page 67 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995836
Page 68 of 299
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fever]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/26/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995837
Page 69 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995838
Page 70 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995839
Page 71 of 299
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Varicose veins in lower limbs ]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995840
Page 72 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[Hormone ]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995841
Page 73 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995842
Page 74 of 299
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Injection site pain]
4.Start Date Time: Feb/1/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/5/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995843
Page 75 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995844
Page 76 of 299
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995845
Page 77 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995846
Page 78 of 299
***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: 12411561 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[ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995847
Page 79 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995848
Page 80 of 299
***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: 12411561 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: //
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995849
Page 81 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995850
Page 82 of 299
***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: 12411561 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?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995851
Page 83 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995852
Page 84 of 299
***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: 12411561 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?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995853
Page 85 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995854
Page 86 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995855
Page 87 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995856
Page 88 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995857
Page 89 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12411561 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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995858
Page 90 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995859
Page 91 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995860
Page 92 of 299
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995861
Page 93 of 299
***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: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995862
Page 94 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995863
Page 95 of 299
***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: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995864
Page 96 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995865
Page 97 of 299
***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: 12411561 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: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995866
Page 98 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995867
Page 99 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/1/2021
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995868
Page 100 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995869
Page 101 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/1/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995870
Page 102 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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: Feb/1/2021
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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995871
Page 103 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 12411561 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:
Feb/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6GZR]
5.bSample ID [BSD7JN]
5.cSample ID [BSD7JP]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995872
Page 104 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 12411561 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:
Feb/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6GZG]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995873
Page 105 of 299
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/1/2021 12:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995874
Page 106 of 299
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995875
Page 107 of 299
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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: Feb/22/2021
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:
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995876
Page 108 of 299
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 12411561 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:
Feb/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKFGN]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995877
Page 109 of 299
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/22/2021 10:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995878
Page 110 of 299
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995879
Page 111 of 299
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995880
Page 112 of 299
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995881
Page 113 of 299
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995882
Page 114 of 299
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995883
Page 115 of 299
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995884
Page 116 of 299
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995885
Page 117 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995886
Page 118 of 299
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995887
Page 119 of 299
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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 Feb-24-2021 15:38:20 (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.
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995888
Page 120 of 299
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormFeb-01-2021 12:05:49 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995889
Page 121 of 299
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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 Feb-24-2021 15:38:20 (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-22-2021 11:36:09 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-05-2021 15:38:16 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995890
Page 122 of 299
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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.
 N/A Feb-01-2021 12:04:59 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Jan-22-2021 05:43:25 (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.
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995891
Page 123 of 299
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 N/A Dec-28-2020 16:02:03 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Nov-14-2020 15:22:42 (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-14-2020 15:19:33 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 16:28:21 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995892
Page 124 of 299
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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.
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995893
Page 125 of 299
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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-02-2020
19:24:28
(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-02-2020
19:24:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995894
Page 126 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-02-2020
19:24:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/2/2020Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995895
Page 127 of 299
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-02-2020
19:24:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12411561Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-02-2020
19:24:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1964Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-02-2020
19:24:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-02-2020
19:24:48
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OFInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995896
Page 128 of 299
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-02-2020
19:24:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLACK OR AFRIC
AN AMERICANInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995897
Page 129 of 299
***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: 12411561 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-02-2020
19:24:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995898
Page 130 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or female
participants bet
ween the ages
of 18 and 55 ye
ars, inclusive, 6
5 and 85 years,
inclusive, or 18
and 85 years, in
clusive, at rand
omization (dep
endent upon stu
dy stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995899
Page 131 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female partic
ipants between the ag
es of 18 and 55 years,
inclusive, 65 and 85 y
ears, inclusive, or 18
and 85 years, inclusiv
e, at randomization (d
ependent upon study
stage)Initial Entry
1.a Criterion met?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995900
Page 132 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995901
Page 133 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n De
scri
ptio
n:Participants wh
o are willing a
nd able to com
ply with all sch
eduled visits, v
accination plan
, laboratory tes
ts, lifestyle con
siderations, an
d other study p
rocedures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995902
Page 134 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideration
s, and other study pro
ceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995903
Page 135 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are
determined by
medical history
, physical exa
mination, and c
linical judgme
nt of the invest
igator to be eli
gible for inclus
ion in the study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995904
Page 136 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN03A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995905
Page 137 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined b
y medical history, ph
ysical examination, a
nd clinical judgment
of the investigator to
be eligible for inclusi
on in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995906
Page 138 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n De
scri
ptio
n:Capable of givi
ng personal sig
ned informed c
onsent, which i
ncludes compli
ance with the r
equirements an
d restrictions li
sted in the ICD
and in this prot
ocol
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995907
Page 139 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995908
Page 140 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving per
sonal signed informe
d consent, which incl
udes compliance with
the requirements and
restrictions listed in t
he ICD and in this pr
otocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995909
Page 141 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. r
ecent (within p
ast year) or acti
ve suicidal idea
tion/behavior/l
ab abnormality
that may increa
se the risk of st
udy participati
on
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995910
Page 142 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psyc
hiatric condition incl.
recent (within past ye
ar) or active suicidal i
deation/behavior/lab
abnormality that may
increase the risk of st
udy participationInitial Entry
2.a Criterion met?
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995911
Page 143 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:2
Crite
rion
Desc
riptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995912
Page 144 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crite
rion
met?
:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995913
Page 145 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995914
Page 146 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
2.c
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of seve
re adverse reac
tion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylaxi
s) to any comp
onent of the st
udy interventio
n(s)
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995915
Page 147 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995916
Page 148 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adv
erse reaction associat
ed with a vaccine and
/or severe allergic rea
ction (eg, anaphylaxis
) to any component of
the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995917
Page 149 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descr
iption:Receipt of
medication
s intended t
o prevent C
OVID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995918
Page 150 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.d Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995919
Page 151 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with kno
wn or suspecte
d immunodefic
iency, as deter
mined by histo
ry and/or labor
atory/physical
examination
Crit
erio
n me
t?:NO
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995920
Page 152 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised
individuals with kno
wn or suspected imm
unodeficiency, as dete
rmined by history and
/or laboratory/physica
l examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995921
Page 153 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scri
ptio
n:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inve
stigator, contra
indicate intram
uscular injectio
n
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995922
Page 154 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995923
Page 155 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the
opinion of the investi
gator, contraindicate i
ntramuscular injectio
nInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995924
Page 156 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or b
reastfeedi
ng
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX11A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995925
Page 157 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995926
Page 158 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX12A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995927
Page 159 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995928
Page 160 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995929
Page 161 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemic
corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995930
Page 162 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
2.j
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of blo
od/plasma pro
ducts or immu
noglobulin, fro
m 60 days bef
ore study inter
vention admini
stration or plan
ned receipt thr
oughout the st
udy
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995931
Page 163 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX14A01
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995932
Page 164 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995933
Page 165 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995934
Page 166 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:16
Crite
rion
Desc
ripti
on:Participation i
n other studie
s involving st
udy interventi
on within 28
days prior to s
tudy entry and
/or during stu
dy participati
on
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995935
Page 167 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995936
Page 168 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
2.l
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous part
icipation in o
ther studies i
nvolving stud
y interventio
n containing
lipid nanopar
ticles
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995937
Page 169 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.l Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(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-02-2020
19:25:30
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995938
Page 170 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
2.m
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Excl
usio
n N
um
ber:22
Crit
erio
n D
escr
ipti
on:Investigator sit
e staff or Pfize
r employees di
rectly involved
in the conduct
of the study, sit
e staff otherwis
e supervised b
y the investigat
or, and their re
spective family
members
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995939
Page 171 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX21A01
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995940
Page 172 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff
or Pfizer employees
directly involved in t
he conduct of the stu
dy, site staff otherwis
e supervised by the i
nvestigator, and their
respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995941
Page 173 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-02-2020
19:25:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995942
Page 174 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 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-02-2020
19:25:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-02-2020
19:25:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-02-2020
19:25:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995943
Page 175 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-02-2020
19:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Hemorrhoi
dectomy
Start Date
:UNK/UN
K/1995
Ongoing: NO
End Date
:
UNK/U
NK/199
5Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-02-2020
19:26:32
(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
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995944
Page 176 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020
19:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HemorrhoidectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-02-2020
19:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-02-2020
19:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1995Initial Entry
1.b
Date Location User Value Reason
Sep-02-2020
19:27:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Allergic
rhinitisInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995945
Page 177 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Start Date: UNK/U
NK/199
0
Ongoing: YES
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995946
Page 178 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Sep-02-2020
19:27:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
19:27:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Allergic rhinitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-02-2020
19:27:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-02-2020
19:27:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995947
Page 179 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c
Date Location User Value Reason
Sep-02-2020
19:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Menopa
use
Start Date: UNK/U
NK/2018
Ongoing: YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995948
Page 180 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020
19:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020
19:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MenopauseInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020
19:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020
19:28:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995949
Page 181 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d
Date Location User Value Reason
Nov-14-2020
15:19:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Lower Lim
b Varicose
Veins
Start Dat
e:May/UNK/
2020
Ongoing: YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995950
Page 182 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Line/MH Number:
Date Location User Value Reason
Nov-14-2020
15:19:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-14-2020
15:19:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Lower Limb Varicos
e VeinsInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-14-2020
15:19:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
May/UNK/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-14-2020
15:19:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995951
Page 183 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
76.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-02-2020
19:27:28ACV0PFEINFP6000  Data Entry:
164.0Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995952
Page 184 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Unit:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.4Initial Entry
7.a
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.4
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995953
Page 185 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-02-2020
19:27:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995954
Page 186 of 299
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020
19:27:55ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995955
Page 187 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020
19:27:55ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995956
Page 188 of 299
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
6.a Test:
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-02-2020
19:27:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995957
Page 189 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-02-2020
19:28:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-02-2020
19:28:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
78945Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995958
Page 190 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
08:51:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
08:51:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
08:52:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
08:51:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995959
Page 191 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Sep-03-2020
08:51:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
08:52:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWX8
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
08:52:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWX8KInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020
08:52:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWX8
LInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995960
Page 192 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Sep-03-2020
08:52:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWX8LInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
08:52:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWX8
MInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020
08:52:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWX8MInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020
08:52:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCTR
6Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995961
Page 193 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.d Sample ID
Date Location User Value Reason
Sep-03-2020
08:52:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTR6Initial Entry
5.e
Date Location User Value Reason
Sep-03-2020
08:52:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BLCTR
7Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-03-2020
08:52:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTR7Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995962
Page 194 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020
08:53:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020
08:53:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020
08:53:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-03-2020
08:53:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995963
Page 195 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Sep-03-2020
08:53:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020
08:53:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BPWXB
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020
08:53:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPWXBGInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995964
Page 196 of 299
***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: 12411561 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-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020
19:29:02
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sep/2/2020 18:37Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995965
Page 197 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020
19:29:02
(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-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995966
Page 198 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-02-2020
19:29:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995967
Page 199 of 299
***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: 12411561 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-02-2020
19:29:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995968
Page 200 of 299
***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: 12411561 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-22-2020
15:48:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995969
Page 201 of 299
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
15:49:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
15:49:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.7
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
15:49:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995970
Page 202 of 299
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Sep-22-2020
15:49:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
15:49:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
15:49:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995971
Page 203 of 299
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020
15:49:46ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995972
Page 204 of 299
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-22-2020
15:49:46ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995973
Page 205 of 299
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
6.a Test:
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-22-2020
15:49:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995974
Page 206 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020
15:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020
15:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020
15:43:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
15:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995975
Page 207 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Sep-22-2020
15:43:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020
15:43:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BPVYD
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
15:43:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BPVYD8Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995976
Page 208 of 299
***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: 12411561 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-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sep/22/2020 14:58Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995977
Page 209 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995978
Page 210 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-22-2020
15:50:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995979
Page 211 of 299
***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: 12411561 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-20-2020
18:40:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995980
Page 212 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
10:15:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
10:15:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
10:15:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
10:15:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995981
Page 213 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Oct-21-2020
10:15:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
10:15:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR74F
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
10:15:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR74FFInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020
10:15:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS5CC
8Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995982
Page 214 of 299
***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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
10:15:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS5CC8Initial Entry
5.c
Date Location User Value Reason
Oct-21-2020
10:15:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS5CC
9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
10:15:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS5CC9Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995983
Page 215 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021
06:02:09
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Jan-21-2021
14:36:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
ddata updated
Jan-18-2021
02:53:30
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Reissued
:OpenedPlease complete
‘Microbiology
Specimen form'
at this visit. Or
confirm date at
which the
missing
information
will be
available for
data entry.
Jan-15-2021
10:57:06
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answere
dResult not
available
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995984
Page 216 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-30-2020
08:46:23
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Opened DM: Kindly
consider to
update missing
COVID TEST
form or else
clarify. Thank
you.
Dec-28-2020
16:03:29
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-28-2020
16:02:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Dec-28-2020
16:02:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidat
eDate of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing.
Please review
and update as
appropriate.
Dec-28-2020
16:02:02
(UTC-03:00)
City of BuenosACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eDate of Visit is
completed but
Date of
Collection in
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0995985
Page 217 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aires both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Dec-28-2020
16:02:02
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Dec/24/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-28-2020
16:02:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995986
Page 218 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/24/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/22/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-21-2021
14:37:53
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Sympt
om Resolved:
Dec/27/2020New
Information
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995987
Page 219 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.a
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR I
NCREASEInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995988
Page 220 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires D COUGH
Sympt
om Pre
sent:NO
4.b Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATHInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995989
Page 221 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Symp
tom
Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995990
Page 222 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.d Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995991
Page 223 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.e Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995992
Page 224 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.f Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:YESInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995993
Page 225 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.g Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995994
Page 226 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.h Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom
Present:NOInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995995
Page 227 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.i Symptoms:
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-28-2020
16:02:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-28-2020
16:02:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Runny
noseInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-28-2020
16:02:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Runny noseInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995996
Page 228 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b
Date Location User Value Reason
Dec-28-2020
16:03:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Snee
zeInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-28-2020
16:03:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SneezeInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995997
Page 229 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995998
Page 230 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 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
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/26/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) CityACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME COROInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0995999
Page 231 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-21-2021
14:36:22
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NALT unknownInitial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0996000
Page 232 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996001
Page 233 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020
16:03:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020
16:03:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020
16:03:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-28-2020
16:03:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996002
Page 234 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Dec-28-2020
16:03:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/24/2020Initial Entry
5.a
Date Location User Value Reason
Dec-28-2020
16:03:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:RW9282
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-28-2020
16:03:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RW92829Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0996003
Page 235 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020
16:04:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020
16:04:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020
16:04:11
(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
Dec-28-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996004
Page 236 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: 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: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
16:04:11
(UTC-03:00) City
of Buenos AiresSubject used self swa
b
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996005
Page 237 of 299
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Dec-28-2020
16:04:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-28-2020
16:04:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-28-2020
16:04:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
090177e196ae3f42\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0996006
Page 238 of 299
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Dec/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411561 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Dec-28-2020
16:04:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:EMER
GENCY
ROOM
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-28-2020
16:04:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
…[truncated]