Document text
Page 1 of 187
***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: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992713
Page 2 of 187
***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: 12411206 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
Aug/18/2020
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992714
Page 3 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411206]
2.Birth Date: 1982
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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992715
Page 4 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/18/2020
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992716
Page 5 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992717
Page 6 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992718
Page 7 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992719
Page 8 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992720
Page 9 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992721
Page 10 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast lump]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992722
Page 11 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/18/2020
2.Weight: [55.5]
3.Unit: kg
4.Height: [152.5]
5.Unit: cm
6.Body Mass Index: [23.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992723
Page 12 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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: Aug/18/2020
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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992724
Page 13 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/18/2020
2.Randomization Number: [53756]
3.Randomization Group: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992725
Page 14 of 187
***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: 12411206 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:
Aug/18/2020
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 [BP5RZW]
5.bSample ID [BP5RZX]
5.cSample ID [BP5RZY]
5.dSample ID [BLCH8T]
5.eSample ID [BLCH8V]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992726
Page 15 of 187
***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: 12411206 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:
Aug/18/2020
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 [BP5RZ6]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992727
Page 16 of 187
***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: 12411206 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: Aug/18/2020 09:26
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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992728
Page 17 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992729
Page 18 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992730
Page 19 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992731
Page 20 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992732
Page 21 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992733
Page 22 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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/9/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992734
Page 23 of 187
***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: 12411206 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/9/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPX0RL]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992735
Page 24 of 187
***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: 12411206 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/9/2020 10:33
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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992736
Page 25 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992737
Page 26 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992738
Page 27 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992739
Page 28 of 187
***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: 12411206 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/7/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWXP2]
5.bSample ID [BHHZSK]
5.cSample ID [BHHZSL]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992740
Page 29 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992741
Page 30 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L 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: 12411206 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:
Mar/3/2021
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 [BRC1HP]
5.bSample ID [BSCYKV]
5.cSample ID [BSCYKW]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992742
Page 31 of 187
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992743
Page 32 of 187
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992744
Page 33 of 187
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992745
Page 34 of 187
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992746
Page 35 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992747
Page 36 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992748
Page 37 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992749
Page 38 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992750
Page 39 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992751
Page 40 of 187
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992752
Page 41 of 187
***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: 12411206 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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992753
Page 42 of 187
***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: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992754
Page 43 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992755
Page 44 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992756
Page 45 of 187
***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: 12411206 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/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992757
Page 46 of 187
***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: 12411206 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: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992758
Page 47 of 187
***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: 12411206 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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992759
Page 48 of 187
***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: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992760
Page 49 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Atypical intraductal hyperpl
asia in left breast Sep/29/2020 U
NK:UNK NO
End Date Time:
Sep/30/2020 UNK:
UNK
Repeating
Pages
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992761
Page 50 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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)[Atypical intraductal hyperplasia in left breast]
4.Start Date Time: Sep/29/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/30/2020 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).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992762
Page 51 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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:
[Breast nodule]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2020390848]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992763
Page 52 of 187
***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: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992764
Page 53 of 187
***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: 12411206 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[ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992765
Page 54 of 187
***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: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992766
Page 55 of 187
***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: 12411206 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: //
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992767
Page 56 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992768
Page 57 of 187
***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: 12411206 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?
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992769
Page 58 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992770
Page 59 of 187
***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: 12411206 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?
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992771
Page 60 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992772
Page 61 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992773
Page 62 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992774
Page 63 of 187
***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: 12411206 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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992775
Page 64 of 187
***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: 12411206 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:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992776
Page 65 of 187
***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: 12411206 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?
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992777
Page 66 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992778
Page 67 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992779
Page 68 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992780
Page 69 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992781
Page 70 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992782
Page 71 of 187
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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 [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992783
Page 72 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992784
Page 73 of 187
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992785
Page 74 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992786
Page 75 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992787
Page 76 of 187
***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: 12411206 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: [ ]
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992788
Page 77 of 187
***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: 12411206 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/7/2020
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992789
Page 78 of 187
***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: 12411206 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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992790
Page 79 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Edson Moreira Approved Mar-08-2021 10:15:06 (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.
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992791
Page 80 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-07-2020 11:53:22 (UTC-03:00) City of
Buenos Aires
FormAug-18-2020 11:38:31 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992792
Page 81 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Edson Moreira Approved Mar-08-2021 10:15:06 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-03-2021 10:45:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-04-2021 17:07:02 (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.
N/A Feb-01-2021 16:53:28 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0992793
Page 82 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
N/A
Edson Moreira Approved Oct-27-2020 17:53:53 (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 Oct-27-2020 17:13:27 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Oct-27-2020 14:58:36 (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 Oct-27-2020 03:27:39 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Oct-26-2020 21:01:44 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0992794
Page 83 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-26-2020 16:19:44 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Oct-22-2020 22:58:10 (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.
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0992795
Page 84 of 187
***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: 12411206 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
Aug-18-2020 11:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020 11:36:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992796
Page 85 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020 11:36:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/18/2020Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992797
Page 86 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-18-2020 11:36:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12411206Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 11:36:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020 11:36:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-18-2020 11:36:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-18-2020 11:36:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMER
ICAN
WHITEInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992798
Page 87 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 11:37:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992799
Page 88 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclu
sion
Num
ber:1
Crite
rion
Descr
iption
:Male or female particip
ants between the ages o
f 18 and 55 years, inclu
sive, 65 and 85 years, i
nclusive, or 18 and 85 y
ears, inclusive, at rando
mization (dependent up
on study stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992800
Page 89 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female participants bet
ween the ages of 18 and 55 year
s, inclusive, 65 and 85 years, in
clusive, or 18 and 85 years, incl
usive, at randomization (depend
ent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:2
Criter
ion De
scripti
on:Participants who are wi
lling and able to compl
y with all scheduled vis
its, vaccination plan, la
boratory tests, lifestyle
considerations, and oth
er study procedures
Criter
ion m
et?:YESInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992801
Page 90 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00
1.b Inclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are willing an
d able to comply with all sched
uled visits, vaccination plan, la
boratory tests, lifestyle consider
ations, and other study procedur
esInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992802
Page 91 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:3
Criter
ion De
scripti
on:Healthy participants w
ho are determined by m
edical history, physical
examination, and clinic
al judgment of the inve
stigator to be eligible f
or inclusion in the stud
y
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992803
Page 92 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are de
termined by medical history, ph
ysical examination, and clinical
judgment of the investigator to
be eligible for inclusion in the s
tudyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:4Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992804
Page 93 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Capable of giving pers
onal signed informed c
onsent, which includes
compliance with the re
quirements and restrict
ions listed in the ICD a
nd in this protocol
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992805
Page 94 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal sign
ed informed consent, which incl
udes compliance with the requir
ements and restrictions listed in
the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992806
Page 95 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion D
escrip
tion:Other medical or psych
iatric condition incl. rec
ent (within past year) o
r active suicidal ideatio
n/behavior/lab abnorma
lity that may increase t
he risk of study particip
ation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric co
ndition incl. recent (within past
year) or active suicidal ideation
/behavior/lab abnormality that
may increase the risk of study p
articipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992807
Page 96 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:2
Criteri
on Desc
ription:Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (
HBV)
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX02A00Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992808
Page 97 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with human i
mmunodeficiency virus (HIV),
hepatitis C virus (HCV), or hep
atitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion N
umber
:3Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992809
Page 98 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:History of severe adver
se reaction associated
with a vaccine and/or s
evere allergic reaction
(eg, anaphylaxis) to an
y component of the stu
dy intervention(s)
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992810
Page 99 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reacti
on associated with a vaccine an
d/or severe allergic reaction (eg
, anaphylaxis) to any componen
t of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:4Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992811
Page 100 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion D
escription:Receipt of medic
ations intended to
prevent COVID-
19
Criterion m
et?:NO
Criterion I
D: (For Pfi
zer use only
):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(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
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992812
Page 101 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised
individuals with know
n or suspected immun
odeficiency, as determi
ned by history and/or l
aboratory/physical exa
mination
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992813
Page 102 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individua
ls with known or suspected im
munodeficiency, as determined
by history and/or laboratory/ph
ysical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0992814
Page 103 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Bleeding diathesis or c
ondition associated wit
h prolonged bleeding t
hat would, in the opini
on of the investigator,
contraindicate intramu
scular injection
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992815
Page 104 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition
associated with prolonged bleed
ing that would, in the opinion o
f the investigator, contraindicat
e intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion De
scription:Women who ar
e pregnant or br
eastfeedingInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0992816
Page 105 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(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
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusion N 12Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992817
Page 106 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
umber:
Criterion D
escription:Previous vaccina
tion with any cor
onavirus vaccine
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any c
oronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992818
Page 107 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:13
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytot
oxic agents or system
ic corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX13A01Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992819
Page 108 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunos
uppressive therapy, such as cyto
toxic agents or systemic cortico
steroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992820
Page 109 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Receipt of blood/plasm
a products or immunog
lobulin, from 60 days
before study interventi
on administration or pl
anned receipt througho
ut the study
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX14A01
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992821
Page 110 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma produc
ts or immunoglobulin, from 60
days before study intervention a
dministration or planned receipt
throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992822
Page 111 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other
studies involving stud
y intervention within
28 days prior to study
entry and/or during st
udy participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX15A01Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992823
Page 112 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other studies in
volving study intervention with
in 28 days prior to study entry
and/or during study participatio
nInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0992824
Page 113 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interve
ntion containing lipi
d nanoparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX16A01
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992825
Page 114 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.l Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participation in other
studies involving study interve
ntion containing lipid nanoparti
clesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:22Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0992826
Page 115 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crite
rion
Descr
iption
:Investigator site staff o
r Pfizer employees dire
ctly involved in the con
duct of the study, site st
aff otherwise supervise
d by the investigator, a
nd their respective fami
ly members
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX21A01
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992827
Page 116 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by the
investigator, and their respectiv
e family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-18-2020 11:37:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992828
Page 117 of 187
***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: 12411206 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
Aug-18-2020 11:38:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 11:38:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020 11:38:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992829
Page 118 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Oct-07-2020 11:54:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Breast lump
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-07-2020 11:54:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 11:54:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Breast lumpInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-07-2020 11:54:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-07-2020 11:54:06
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992830
Page 119 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992831
Page 120 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
55.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
152.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992832
Page 121 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.9Initial Entry
7.a
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.4
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992833
Page 122 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 11:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992834
Page 123 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992835
Page 124 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 11:39:34
(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
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Aug-18-2020 11:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992836
Page 125 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-18-2020 11:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020 11:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
53756Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992837
Page 126 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 16:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 16:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 16:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 16:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-18-2020 16:17:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0992838
Page 127 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 16:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5RZWInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 16:17:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RZWInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020 16:17:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5RZXInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020 16:17:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RZXInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020 16:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5RZYInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-18-2020 16:17:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RZYInitial Entry
5.d
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0992839
Page 128 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-18-2020 16:18:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCH8TInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020 16:18:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCH8TInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020 16:18:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCH8VInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 16:18:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BLCH8VInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(
FDA-CBER-2021-5683-0992840
Page 129 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 16:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 16:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020 16:14:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-18-2020 16:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-18-2020 16:14:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992841
Page 130 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 16:14:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5RZ6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020 16:14:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RZ6Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992842
Page 131 of 187
***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: 12411206 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
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/18/2020 09:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992843
Page 132 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-18-2020 11:41:06
(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
Aug-18-2020 11:41:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992844
Page 133 of 187
***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: 12411206 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
Aug-18-2020 11:41:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992845
Page 134 of 187
***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: 12411206 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-09-2020 11:40:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992846
Page 135 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-09-2020 11:41:48 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992847
Page 136 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresSymptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992848
Page 137 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992849
Page 138 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992850
Page 139 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992851
Page 140 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992852
Page 141 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h Symptom:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ES
S
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992853
Page 142 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992854
Page 143 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.c
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020 11:41:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992855
Page 144 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020 11:42:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020 11:42:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.5
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 11:42:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-09-2020 11:42:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020 11:42:05
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992856
Page 145 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 11:42:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992857
Page 146 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992858
Page 147 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020 11:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992859
Page 148 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 13:21:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 13:21:34
(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-09-2020 13:21:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992860
Page 149 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-09-2020 13:21:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPX0RLInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 13:21:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPX0RLInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992861
Page 150 of 187
***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: 12411206 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-09-2020 11:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020 11:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020 11:42:39
(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 08:57:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-23-2020 08:04:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The date of
vaccination is
09Sep2020
Sep-22-2020 10:43:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened eDiary: Per eDiary
records,
vaccination date is
10-Sep-2020.
Please reconcile
and update or
confirm in the
query response as
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992862
Page 151 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
appropriate.
Thanks
Sep-09-2020 11:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/9/2020 10:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020 11:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020 11:42:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020 11:42:39
(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-09-2020 11:42:39
(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-09-2020 11:42:39
(UTC-03:00) City ofACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992863
Page 152 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992864
Page 153 of 187
***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: 12411206 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-07-2020 11:48:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992865
Page 154 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-07-2020 11:50:01 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992866
Page 155 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresSymptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992867
Page 156 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992868
Page 157 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992869
Page 158 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992870
Page 159 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992871
Page 160 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h Symptom:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ES
S
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992872
Page 161 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992873
Page 162 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.c
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 11:50:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992874
Page 163 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 09:51:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 09:51:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020 09:51:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-08-2020 09:51:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-08-2020 09:51:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992875
Page 164 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-08-2020 09:51:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPWXP2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020 09:51:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPWXP2Initial Entry
5.b
Date Location User Value Reason
Oct-08-2020 09:51:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHHZSKInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-08-2020 09:51:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHHZSKInitial Entry
5.c
Date Location User Value Reason
Oct-08-2020 09:51:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BHHZSLInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-08-2020 09:51:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BHHZSLInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992876
Page 165 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 10:45:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Mar/3/2021Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992877
Page 166 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 11:09:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 11:09:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 11:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 11:09:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-03-2021 11:09:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992878
Page 167 of 187
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Mar-03-2021 11:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRC1HPInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 11:09:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRC1HPInitial Entry
5.b
Date Location User Value Reason
Mar-03-2021 11:09:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BSCYKVInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021 11:09:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BSCYKVInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021 11:09:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BSCYKWInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-03-2021 11:09:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BSCYKWInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992879
Page 168 of 187
***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: 12411206 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-07-2020 11:50:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 11:50:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 11:50:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992880
Page 169 of 187
***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: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992881
Page 170 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020 06:30:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed event term updated
in SDB. Issue
resolved
Oct-28-2020 11:56:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The AEM will be
submitted
Oct-28-2020 00:09:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON
2:Thankk you for
the update. Please
confirm if a follow
up AEM form was
submitted to update
the event term in
Safety database.
Oct-27-2020 17:13:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-27-2020 17:13:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Atypical intraductal hyperplas
ia in left breastTranscription Error
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992882
Page 171 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-27-2020 07:21:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1: The
event term in Inform
was recorded as
'BREAST NODULE
REMOVAL'. Per
Clinical review
event term cannot be
a surgical procedure
but the underlying
diagnosis. Please
review the AE term
and update to a term
for which the
procedure was
perform
Oct-27-2020 03:27:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON 1: The
event term in Inform
was recorded as
'BREAST NODULE
REMOVAL'. Per
Clinical review
event term cannot be
a surgical procedure
but the underlying
diagnosis. Please
review the AE term
and update to a term
for which the
procedure was
perform
Oct-26-2020 16:23:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered A SAE FORM will
be sent to update the
diagnosis
Oct-25-2020 10:28:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020390848
Per Clinical, event
term cannot be a
surgical procedure
but the underlying
diagnosis. Please
review and enter the
AE term for which
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992883
Page 172 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
the procedure was
performed.
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Breast nodule removalInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 16:19:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/29/2020 UNK:UNKTranscription Error
Oct-20-2020 09:30:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-15-2020 17:01:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-15-2020 17:01:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/30/2020 UNK:UNKTranscription Error
Oct-15-2020 11:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per source, start
date is 30Sep2020.
Please verify and
update, if
applicable. Thank
you.
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/29/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/30/2020 UNK:UNKInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992884
Page 173 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 11:57:53
(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
Oct-27-2020 03:29:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-27-2020 03:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Oct-26-2020 16:20:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE Breast
nodule removal:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-26-2020 16:20:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Oct-26-2020 16:20:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NOTranscription Error
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992885
Page 174 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Did this serious event result i
n death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important se
rious event
NO
Oct-25-2020 10:27:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Opened SAE
RECON:Breast
nodule
removal(Onset
date:29Sep2020)
was reported as
serious to Safety
database but non
serious on AE CRF.
Confirm
seriousness. If this
event is not serious,
please submit a
follow up AEM
form to downgrade
event in Safety
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992886
Page 175 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-16-2020 06:52:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed seriousness
downgraded to NO
Oct-15-2020 10:03:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Oct-15-2020 10:03:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOMH reported
elective procedure
Oct-12-2020 07:52:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1:
The term appears to
be a procedure.
Please confirm if
the event being
reported is breast
nodule.
Oct-09-2020 08:56:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Candidate SAE RECON: For
Clinical review
Oct-08-2020 11:59:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered It will be reported
Oct-08-2020 08:20:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:Breast
nodule
removal(Onset
date:29Sep2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Oct-07-2020 11:57:53
(UTC-03:00) City ofACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Breast
nodule removal:
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992887
Page 176 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important se
rious event
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
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992888
Page 177 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-28-2020
05:02:35
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Query 2
: ClosedResponse
satisfies query
Oct-27-2020
17:14:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2
: Answe
redTranscription
Error
Oct-27-2020
17:14:27
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to
:
OTH
ER
If
Ot
her
, spTranscription
Error
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992889
Page 178 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
ecif
y:
B
re
as
t
n
o
d
ul
e
Oct-27-2020
09:16:19
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2
: Opene
dPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field [Benign
nodule]. Any
symptoms,
AEs or other
key data
should be
collected on
the
appropriate
page. Please
review and
update as
necessary.
Oct-08-2020
19:06:28
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Hayley Wyper Query 1
: ClosedResponse
satisfies query
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b)
(4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0992890
Page 179 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-08-2020
12:00:18
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redTranscription
Error
Oct-08-2020
12:00:18
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to
:
OTH
ER
If
Ot
her
, sp
ecif
y:
B
e
ni
g
n
n
o
d
ul
eTranscription
Error
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0992891
Page 180 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-08-2020
07:29:21
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Hayley Wyper Query 1
: Opene
dCLINQUERY:
The indication
for the
procedure
should be
captured here.
The MH
reports the
Breast Lump.
Oct-07-2020
11:57:53
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to
:
OTH
ER
If
Ot
her
, sp
ecif
y:
S
ur
g
er
yInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0992892
Page 181 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-07-2020 11:57:53
(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
Oct-07-2020 11:57:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992893
Page 182 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-27-2020 03:27:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020390848Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992894
Page 183 of 187
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 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-01-2021 16:53:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0992895
Page 184 of 187
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-01-2021 16:53:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0992896
Page 185 of 187
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-01-2021 16:53:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-01-2021 16:53:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0992897
Page 186 of 187
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-07-2020 11:50:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-18-2020 11:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-18-2020 11:38:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-07-2020 11:50:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-18-2020 11:40:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
Aug-18-2020 11:38:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/18/2020Initial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992898
Page 187 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411206 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 22:58:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Edson
MoreiraData Entry:
Click Here to EnableInitial Entry
090177e196ae3f78\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0992899