125742 S1 M5 CRF c4591001 1241 12411514

Document text

Page 1 of 252
***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: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995518
Page 2 of 252
***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: 12411514 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/1/2020
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995519
Page 3 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411514]
2.Birth Date: 1987
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
WHITE
6.Racial Designation:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995520
Page 4 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995521
Page 5 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes
compliance with the requirements and restrictions listed in the ICD and in
this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995522
Page 6 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995523
Page 7 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or laboratory/physical
examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that
would, in the opinion of the investigator, contraindicate intramuscular
injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995524
Page 8 of 252
***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: 12411514 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
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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995525
Page 9 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995526
Page 10 of 252
***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: 12411514 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:[Migraine]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995527
Page 11 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [59.5]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [22.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995528
Page 12 of 252
***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: 12411514 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/1/2020
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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995529
Page 13 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [77063]
3.Randomization Group: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995530
Page 14 of 252
***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: 12411514 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/1/2020
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 [BPT140]
5.bSample ID [BPT141]
5.cSample ID [BPT14H]
5.dSample ID [BLCTM6]
5.eSample ID [BLCTM7]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995531
Page 15 of 252
***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: 12411514 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/1/2020
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 [BPT132]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995532
Page 16 of 252
***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: 12411514 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/1/2020 16:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995533
Page 17 of 252
***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: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995534
Page 18 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995535
Page 19 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995536
Page 20 of 252
***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: 12411514 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/23/2020
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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995537
Page 21 of 252
***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: 12411514 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/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVYFG]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995538
Page 22 of 252
***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: 12411514 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/23/2020 16:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995539
Page 23 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995540
Page 24 of 252
***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: 12411514 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/21/2020
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 [BR74KH]
5.bSample ID [BS5BSD]
5.cSample ID [BS5BSF]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995541
Page 25 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995542
Page 26 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/25/2021
2.Date of First Symptom Started: Feb/24/2021
3.Symptoms Ongoing? YES
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? YES
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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995543
Page 27 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
5.bSymptoms - Other Text: [Headache]
5.cSymptoms - Other Text: [Asthenia]
5.dSymptoms - Other Text: [Nasal congestion]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995544
Page 28 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Feb/26/20
21 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995545
Page 29 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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: Feb/26/2021
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: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995546
Page 30 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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:
Feb/26/2021
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 [RW92883]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995547
Page 31 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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 [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995548
Page 32 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995549
Page 33 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995550
Page 34 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identif
ierCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995551
Page 35 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995552
Page 36 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995553
Page 37 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995554
Page 38 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995555
Page 39 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995556
Page 40 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995557
Page 41 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995558
Page 42 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995559
Page 43 of 252
***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: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995560
Page 44 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995561
Page 45 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995562
Page 46 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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 % [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995563
Page 47 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995564
Page 48 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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):[ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995565
Page 49 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995566
Page 50 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995567
Page 51 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995568
Page 52 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995569
Page 53 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995570
Page 54 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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 [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995571
Page 55 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995572
Page 56 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995573
Page 57 of 252
***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: 12411514 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995574
Page 58 of 252
***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: 12411514 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: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995575
Page 59 of 252
***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: 12411514 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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995576
Page 60 of 252
***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: 12411514 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 [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995577
Page 61 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Injection site pain  Jan/28/2021 UN
K:UNK NO
End Date Time:
Jan/29/2021 UNK:U
NK
 Repeating
Pages
 2.ADVERSE E
VENT 2  Maternal exposure durin
g pregnancy Feb/5/2021 UN
K:UNK YES  Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995578
Page 62 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Injection site pain]
4.Start Date Time: Jan/28/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995579
Page 63 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995580
Page 64 of 252
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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)[Maternal exposure during pregnancy]
4.Start Date Time: Feb/5/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995581
Page 65 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pregnancy]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995582
Page 66 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995583
Page 67 of 252
***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: 12411514 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[ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995584
Page 68 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995585
Page 69 of 252
***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: 12411514 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: //
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995586
Page 70 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995587
Page 71 of 252
***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: 12411514 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?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995588
Page 72 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995589
Page 73 of 252
***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: 12411514 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?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995590
Page 74 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995591
Page 75 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995592
Page 76 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995593
Page 77 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995594
Page 78 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995595
Page 79 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995596
Page 80 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995597
Page 81 of 252
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995598
Page 82 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995599
Page 83 of 252
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995600
Page 84 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995601
Page 85 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995602
Page 86 of 252
***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: 12411514 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: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995603
Page 87 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995604
Page 88 of 252
***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: 12411514 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
Jan/27/2021
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995605
Page 89 of 252
***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: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995606
Page 90 of 252
***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: 12411514 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 :Jan/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995607
Page 91 of 252
***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: 12411514 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: Jan/27/2021
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:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995608
Page 92 of 252
***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: 12411514 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/27/2021
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 [BRKC1S]
5.bSample ID [BSCZ70]
5.cSample ID [BSCZ71]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995609
Page 93 of 252
***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: 12411514 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:
Jan/27/2021
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 [BRKC24]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995610
Page 94 of 252
***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: 12411514 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: Jan/27/2021 10:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995611
Page 95 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995612
Page 96 of 252
***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: 12411514 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/17/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995613
Page 97 of 252
***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: 12411514 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/17/2021
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 [BRKF9V]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995614
Page 98 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995615
Page 99 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995616
Page 100 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995617
Page 101 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995618
Page 102 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995619
Page 103 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995620
Page 104 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995621
Page 105 of 252
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/17/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995622
Page 106 of 252
***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: 12411514 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/21/2020
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995623
Page 107 of 252
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 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
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995624
Page 108 of 252
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-12-2021 16:54:07 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995625
Page 109 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Feb-18-2021 09:16:11 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995626
Page 110 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormJan-27-2021 11:23:12 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995627
Page 111 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormFeb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995628
Page 112 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
1Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995629
Page 113 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
2Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995630
Page 114 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
3Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995631
Page 115 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
4Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995632
Page 116 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
5Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995633
Page 117 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995634
Page 118 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
7Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995635
Page 119 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
8Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995636
Page 120 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
9Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995637
Page 121 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
10Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995638
Page 122 of 252
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
11Feb-17-2021 17:05:13 (UTC-03:00) City of
Buenos AiresNot Done
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995639
Page 123 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-12-2021 16:54:07 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-11-2021 08:38:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-02-2021 18:58:34 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-26-2021 13:51:03 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995640
Page 124 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
N/A
 Approved Feb-24-2021 15:45:09 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-17-2021 16:44:22 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira  Approved Feb-02-2021 14:33:39 (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 Jan-27-2021 11:22:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995641
Page 125 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
 Approved Oct-26-2020 16:06:02 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995642
Page 126 of 252
***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: 12411514 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-01-2020 17:33:04
(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-01-2020 17:33:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995643
Page 127 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 17:33:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/1/2020Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995644
Page 128 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 17:32:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12411514Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 17:32:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1987Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 17:33:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 17:33:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 17:33:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AME
RICAN
WHITEInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995645
Page 129 of 252
***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: 12411514 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-01-2020 17:33:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995646
Page 130 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Male or female partici
pants between the ages
of 18 and 55 years, inc
lusive, 65 and 85 years
, inclusive, or 18 and 8
5 years, inclusive, at ra
ndomization (depende
nt upon study stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995647
Page 131 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants be
tween the ages of 18 and 55 ye
ars, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, i
nclusive, at randomization (de
pendent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:2
Criter
ion D
escrip
tion:Participants who are
willing and able to co
mply with all schedule
d visits, vaccination pl
an, laboratory tests, lif
estyle considerations,
and other study proce
duresInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995648
Page 132 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995649
Page 133 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing an
d able to comply with all sche
duled visits, vaccination plan, l
aboratory tests, lifestyle consid
erations, and other study proce
duresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:3Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995650
Page 134 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion D
escrip
tion:Healthy participants w
ho are determined by
medical history, physi
cal examination, and c
linical judgment of the
investigator to be eligi
ble for inclusion in the
study
Criter
ion m
et?:YES
Criter
ion I
D: (F
or Pfi
zer us
e only
):IN03A00
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995651
Page 135 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are d
etermined by medical history,
physical examination, and clin
ical judgment of the investigat
or to be eligible for inclusion i
n the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:4Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995652
Page 136 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion D
escrip
tion:Capable of giving pers
onal signed informed
consent, which includ
es compliance with th
e requirements and res
trictions listed in the I
CD and in this protoc
ol
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995653
Page 137 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the re
quirements and restrictions list
ed in the ICD and in this proto
colInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:1Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995654
Page 138 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crite
rion
Descr
iption
:Other medical or psyc
hiatric condition incl. r
ecent (within past year
) or active suicidal ide
ation/behavior/lab abn
ormality that may incr
ease the risk of study p
articipation
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric c
ondition incl. recent (within pa
st year) or active suicidal ideat
ion/behavior/lab abnormality t
hat may increase the risk of stu
dy participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995655
Page 139 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Known infection wit
h human immunodef
iciency virus (HIV),
hepatitis C virus (HC
V), or hepatitis B vir
us (HBV)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX02A00Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995656
Page 140 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human i
mmunodeficiency virus (HIV),
hepatitis C virus (HCV), or he
patitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:3Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995657
Page 141 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:History of severe adve
rse reaction associated
with a vaccine and/or
severe allergic reactio
n (eg, anaphylaxis) to
any component of the
study intervention(s)
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995658
Page 142 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse react
ion associated with a vaccine a
nd/or severe allergic reaction (
eg, anaphylaxis) to any compo
nent of the study intervention(
s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion
Number:4Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995659
Page 143 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion
Descriptio
n:Receipt of medic
ations intended t
o prevent COVI
D-19
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intende
d to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995660
Page 144 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:8
Criter
ion De
scripti
on:Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determ
ined by history and/or
laboratory/physical ex
amination
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX08A00Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995661
Page 145 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individu
als with known or suspected i
mmunodeficiency, as determin
ed by history and/or laboratory
/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:10Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995662
Page 146 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the o
pinion of the investiga
tor, contraindicate intr
amuscular injection
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995663
Page 147 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition
associated with prolonged blee
ding that would, in the opinion
of the investigator, contraindic
ate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:11Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995664
Page 148 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion De
scription:Women who ar
e pregnant or b
reastfeeding
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or br
eastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995665
Page 149 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:12
Criterion D
escription:Previous vaccin
ation with any c
oronavirus vacci
ne
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX12A00Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995666
Page 150 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:13Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995667
Page 151 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descr
iption:Subjects who receiv
e immunosuppressiv
e therapy, such as cy
totoxic agents or sys
temic corticosteroid
s
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX13A01
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995668
Page 152 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunos
uppressive therapy, such as cyt
otoxic agents or systemic corti
costeroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:15Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995669
Page 153 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt th
roughout the study
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX14A01
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995670
Page 154 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma produ
cts or immunoglobulin, from 6
0 days before study interventio
n administration or planned re
ceipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995671
Page 155 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:16
Criteri
on Des
criptio
n:Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX15A01Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995672
Page 156 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies i
nvolving study intervention wi
thin 28 days prior to study ent
ry and/or during study particip
ationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:17Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995673
Page 157 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descri
ption:Previous participati
on in other studies i
nvolving study inter
vention containing l
ipid nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX16A01
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995674
Page 158 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.l Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other
studies involving study interve
ntion containing lipid nanopar
ticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(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-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995675
Page 159 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crite
rion
Descr
iption
:Investigator site staff
or Pfizer employees di
rectly involved in the
conduct of the study, s
ite staff otherwise sup
ervised by the investig
ator, and their respecti
ve family members
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995676
Page 160 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer
employees directly involved i
n the conduct of the study, site
staff otherwise supervised by t
he investigator, and their respe
ctive family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-01-2020 17:33:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995677
Page 161 of 252
***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: 12411514 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-01-2020 17:34:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 17:34:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 17:34:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995678
Page 162 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 17:34:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Migraine
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:34:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 17:34:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
MigraineInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 17:34:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020 17:34:41 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0995679
Page 163 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresYES
1.b
Date Location User Value Reason
Sep-01-2020 17:35:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Allergic rhin
itis
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995680
Page 164 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:35:07
(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-01-2020 17:35:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Allergic rhinitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 17:35:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 17:35:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995681
Page 165 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
59.5Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
162.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995682
Page 166 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.7Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.9
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995683
Page 167 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:35:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995684
Page 168 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995685
Page 169 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 17:35:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995686
Page 170 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 17:36:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 17:36:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
77063Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995687
Page 171 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 19:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 19:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 19:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 19:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995688
Page 172 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 19:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT140Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 19:27:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT140Initial Entry
5.b
Date Location User Value Reason
Sep-01-2020 19:27:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT141Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 19:27:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT141Initial Entry
5.c
Date Location User Value Reason
Sep-01-2020 19:28:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT14HInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 19:28:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT14HInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995689
Page 173 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.d
Date Location User Value Reason
Sep-01-2020 19:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCTM6Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 19:28:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTM6Initial Entry
5.e
Date Location User Value Reason
Sep-01-2020 19:28:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCTM7Initial Entry
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 19:28:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTM7Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995690
Page 174 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 17:45:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 17:45:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995691
Page 175 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:45:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT132Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 17:45:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT132Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995692
Page 176 of 252
***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: 12411514 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-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/1/2020 16:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995693
Page 177 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020 17:36:25
(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-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 17:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995694
Page 178 of 252
***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: 12411514 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-01-2020 17:36:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995695
Page 179 of 252
***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: 12411514 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-23-2020 17:03:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995696
Page 180 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 17:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020 17:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.5
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 17:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-23-2020 17:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020 17:03:49 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0995697
Page 181 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresC
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 17:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995698
Page 182 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995699
Page 183 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-23-2020 17:04:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995700
Page 184 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 11:12:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 11:12:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 11:12:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 11:12:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-24-2020 11:12:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995701
Page 185 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-24-2020 11:12:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVYFGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 11:12:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVYFGInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995702
Page 186 of 252
***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: 12411514 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-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/23/2020 16:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995703
Page 187 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020 17:04:32
(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-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-23-2020 17:04:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995704
Page 188 of 252
***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: 12411514 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-21-2020 18:40:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995705
Page 189 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 09:53:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 09:53:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 09:53:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 09:53:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 09:53:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995706
Page 190 of 252
***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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-22-2020 09:53:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR74KHInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 09:53:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR74KHInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 09:53:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS5BSDInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 09:53:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS5BSDInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 09:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS5BSFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 09:53:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS5BSFInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995707
Page 191 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 13:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-26-2021 13:51:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-26-2021 13:51:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Feb-26-2021 13:51:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/25/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-26-2021 13:51:01
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995708
Page 192 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0995709
Page 193 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/25/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995710
Page 194 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995711
Page 195 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.c Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995712
Page 196 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995713
Page 197 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.f Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995714
Page 198 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.h
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995715
Page 199 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.i Symptoms:
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-26-2021 13:51:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-26-2021 13:52:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other: FatigueInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-26-2021 13:52:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021 13:52:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other
:Headach
eInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995716
Page 200 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-26-2021 13:52:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021 13:52:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other: AstheniaInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Feb-26-2021 13:52:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
AstheniaInitial Entry
5.d
Date Location User Value Reason
Feb-26-2021 13:53:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:Nasal conges
tionInitial Entry
5.d Symptoms - Other Text:
Date Location User Value Reason
Feb-26-2021 13:53:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nasal congestionInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995717
Page 201 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995718
Page 202 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 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
Mar-11-2021 08:38:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/26/2021Transcription
Error
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/22/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995719
Page 203 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Trade Name:
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-11-2021 08:38:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
POSITIVETranscription
Error
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-01-2021 10:19:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NALT unknownInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995720
Page 204 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 13:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 13:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 13:53:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 13:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 13:53:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995721
Page 205 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Feb-26-2021 13:53:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: RW92883Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 13:53:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RW92883Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995722
Page 206 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: 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: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 13:53:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 13:53:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 13:53:55
(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
Feb-26-2021 13:53:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subject used self swabInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995723
Page 207 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitione
r:SPECIA
LIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGEN
CY ROOM
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995724
Page 208 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995725
Page 209 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGENT
CARE
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:TELEPHONE
CONSULTAT
ION
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995726
Page 210 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995727
Page 211 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Feb-26-2021 13:54:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995728
Page 212 of 252
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/25/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-26-2021 13:54:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-12-2021 12:56:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical Query:
COVID-19
diagnosis should
be entered on this
CRF as there was
a local positive
test and symptoms
recorded. Please
update diagnosis
to COVID-19.
Feb-26-2021 13:54:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 13:54:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995729
Page 213 of 252
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-21-2020 18:40:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020 18:40:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020 18:40:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995730
Page 214 of 252
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995731
Page 215 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995732
Page 216 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/29/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995733
Page 217 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995734
Page 218 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-17-2021 17:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0995735
Page 219 of 252
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Maternal exposure during preg
nancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 13:28:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Escalated to CRA
Mar-09-2021 14:14:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered As per eCRF v14
section 8.51.2.5 -
In the absence of
ultrasound, the
data from the last
menstrual period
(LMP) should be
used to estimate
date of conception.
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0995736
Page 220 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Mar-09-2021 12:14:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Per CRF CG
section 8.50.2.5
(please review),
The onset date for
EDP is = LMP, not
conception date.
Please revise and
update.
Mar-09-2021 09:17:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered data is correct. The
conception date
was calculated
using the LMP
date
Mar-08-2021 19:24:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Per report, LMP is
22Jan2021. Pls
clarify if the
information is
inaccurate. Thanks
Mar-04-2021 09:33:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The onset date was
calculated
according to LMP
Mar-04-2021 08:47:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened That is correct.
Additionally, date
of onset is
determined by
ultrasound results
or date of last
menstrual period.
Per report, LMP is
22Jan2021. Pls
advise why the
date of onset in
this form is
5Feb2021? thanks
Feb-24-2021 11:15:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered According to V12
CRF "If
conception
occurred after
vaccination 1, Date
of AE Onset =
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0995737
Page 221 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of
conception, for
both male and
female
participants."
Feb-24-2021 10:42:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical monitor_
As per V12 CRF
CG 8.50.2.5, Date
of onset is
determined by
ultrasound results
or date of last
menstrual period.
Per report, LMP is
22Jan2021. Pls
revise/update
accordingly.
Thanks
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/5/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021 09:16:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
090177e196ae3f48\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0995738
Page 222 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411514 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-18-2021 09:15:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
…[truncated]