Document text
Page 1 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992387
Page 2 of 326
***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: 12411197 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/17/2020
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992388
Page 3 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411197]
2.Birth Date: 1976
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992389
Page 4 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992390
Page 5 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992391
Page 6 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992392
Page 7 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992393
Page 8 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992394
Page 9 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992395
Page 10 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992396
Page 11 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992397
Page 12 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992398
Page 13 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [109.0]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [37.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992399
Page 14 of 326
***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: 12411197 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/17/2020
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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992400
Page 15 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [53662]
3.Randomization Group: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992401
Page 16 of 326
***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: 12411197 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/17/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5RYM]
5.bSample ID [BP5RYN]
5.cSample ID [BP5RYP]
5.dSample ID [BLCH88]
5.eSample ID [BLCH89]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992402
Page 17 of 326
***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: 12411197 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/17/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5RX6]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992403
Page 18 of 326
***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: 12411197 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/17/2020 21:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992404
Page 19 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992405
Page 20 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992406
Page 21 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992407
Page 22 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992408
Page 23 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992409
Page 24 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992410
Page 25 of 326
***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: 12411197 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/8/2020
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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992411
Page 26 of 326
***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: 12411197 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/8/2020
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 [BPX0NX]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992412
Page 27 of 326
***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: 12411197 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/8/2020 16:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992413
Page 28 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992414
Page 29 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992415
Page 30 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992416
Page 31 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992417
Page 32 of 326
***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: 12411197 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 [BPWXRV]
5.bSample ID [BHHZW7]
5.cSample ID [BHHZW8]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992418
Page 33 of 326
***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: 12411197 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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992419
Page 34 of 326
***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: 12411197 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: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992420
Page 35 of 326
***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: 12411197 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 [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992421
Page 36 of 326
***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: 12411197 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 [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992422
Page 37 of 326
***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: 12411197 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?
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992423
Page 38 of 326
***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: 12411197 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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992424
Page 39 of 326
***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: 12411197 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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992425
Page 40 of 326
***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: 12411197 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 [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992426
Page 41 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992427
Page 42 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992428
Page 43 of 326
***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: 12411197 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: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992429
Page 44 of 326
***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: 12411197 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: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992430
Page 45 of 326
***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: 12411197 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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992431
Page 46 of 326
***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: 12411197 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 [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992432
Page 47 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 Left ankle sprain Sep/24/2020
UNK:UNK NO
End Date Time:
Sep/30/2020 UN
K:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 Dental inflammati
on Sep/28/2020
UNK:UNK NO
End Date Time:
Oct/12/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT
3 Fatigue Jan/22/2021
18:00 NO
End Date Time:
Jan/23/2021 UN
K:UNK
Repeating
Pages
4.ADVERS
E EVENT
4 Chills Jan/22/2021
18:00 NO
End Date Time:
Jan/23/2021 UN
K:UNK
Repeating
Pages
5.ADVERS
E EVENT
5 Injection site pain Jan/22/2021
18:00 NO
End Date Time:
Jan/24/2021 UN
K:UNKRepeating
Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992433
Page 48 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
6.ADVERS
E EVENT
6 Ipsilateral axillary
lymphadenopathy Jan/22/2021
18:00 NO
End Date Time:
Jan/24/2021 UN
K:UNK
Repeating
Pages
7.ADVERS
E EVENT
7 Fever Feb/10/2021
22:00 NO
End Date Time:
Feb/12/2021 UN
K:UNK
Repeating
Pages
8.ADVERS
E EVENT
8 Fatigue Feb/10/2021
22:00 NO
End Date Time:
Feb/12/2021 UN
K:UNK
Repeating
Pages
9.ADVERS
E EVENT
9 Myalgia Feb/10/2021
22:00 NO
End Date Time:
Feb/12/2021 UN
K:UNK
Repeating
Pages
10.ADVERS
E EVENT
10 Injection site pain Feb/10/2021
22:00 NO
End Date Time:
Feb/12/2021 UN
K:UNKRepeating
Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992434
Page 49 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992435
Page 50 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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)[Left ankle sprain]
4.Start Date Time: Sep/24/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/30/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992436
Page 51 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Physical activity]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992437
Page 52 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992438
Page 53 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Dental inflammation]
4.Start Date Time: Sep/28/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/12/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992439
Page 54 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bacterial tooth abscess]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992440
Page 55 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992441
Page 56 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fatigue]
4.Start Date Time: Jan/22/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/23/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992442
Page 57 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992443
Page 58 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992444
Page 59 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Chills]
4.Start Date Time: Jan/22/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/23/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992445
Page 60 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992446
Page 61 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992447
Page 62 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Injection site pain]
4.Start Date Time: Jan/22/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/24/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992448
Page 63 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992449
Page 64 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992450
Page 65 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Ipsilateral axillary lymphadenopathy]
4.Start Date Time: Jan/22/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/24/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992451
Page 66 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992452
Page 67 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992453
Page 68 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fever]
4.Start Date Time: Feb/10/2021 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992454
Page 69 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992455
Page 70 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992456
Page 71 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fatigue]
4.Start Date Time: Feb/10/2021 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992457
Page 72 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992458
Page 73 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992459
Page 74 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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: [9]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Myalgia]
4.Start Date Time: Feb/10/2021 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992460
Page 75 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992461
Page 76 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992462
Page 77 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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: [10]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Injection site pain]
4.Start Date Time: Feb/10/2021 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992463
Page 78 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992464
Page 79 of 326
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992465
Page 80 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992466
Page 81 of 326
***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: 12411197 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[ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992467
Page 82 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992468
Page 83 of 326
***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: 12411197 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: //
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992469
Page 84 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992470
Page 85 of 326
***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: 12411197 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?
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992471
Page 86 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992472
Page 87 of 326
***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: 12411197 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?
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992473
Page 88 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992474
Page 89 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992475
Page 90 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992476
Page 91 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992477
Page 92 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992478
Page 93 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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?
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992479
Page 94 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992480
Page 95 of 326
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992481
Page 96 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992482
Page 97 of 326
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992483
Page 98 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992484
Page 99 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992485
Page 100 of 326
***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: 12411197 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: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992486
Page 101 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992487
Page 102 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992488
Page 103 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992489
Page 104 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992490
Page 105 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/22/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992491
Page 106 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTKS0]
5.bSample ID [BRT77L]
5.cSample ID [BRT77M]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992492
Page 107 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTKSN]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992493
Page 108 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/22/2021 11:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992494
Page 109 of 326
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992495
Page 110 of 326
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/10/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992496
Page 111 of 326
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
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 [BRKF0R]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992497
Page 112 of 326
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 10:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992498
Page 113 of 326
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992499
Page 114 of 326
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/10/2021
3.Comments: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992500
Page 115 of 326
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992501
Page 116 of 326
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992502
Page 117 of 326
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992503
Page 118 of 326
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992504
Page 119 of 326
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992505
Page 120 of 326
***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: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992506
Page 121 of 326
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992507
Page 122 of 326
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 18:38:44 (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.
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0992508
Page 123 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormAug-17-2020 22:00:44 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992509
Page 124 of 326
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormJan-22-2021 11:56:41 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992510
Page 125 of 326
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 18:38:44 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Mar-10-2021 11:46:42 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-12-2021 11:06:39 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992511
Page 126 of 326
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Feb-10-2021 11:49:28 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Jan-27-2021 13:37:15 (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.
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0992512
Page 127 of 326
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
N/A Jan-22-2021 11:55:52 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Nov-14-2020 12:49:52 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Nov-13-2020 14:55:35 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Oct-22-2020 17:29:42 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0992513
Page 128 of 326
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411197 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.
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992514
Page 129 of 326
***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: 12411197 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-17-2020
21:59:14
(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-17-2020
21:59:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992515
Page 130 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020
21:59:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/17/2020Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992516
Page 131 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020
21:59:07
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12411197Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020
21:59:04
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1976Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020
21:59:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020
21:59:33
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OFInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992517
Page 132 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020
21:59:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992518
Page 133 of 326
***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: 12411197 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-17-2020
21:59:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992519
Page 134 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or female
participants bet
ween the ages
of 18 and 55 ye
ars, inclusive, 6
5 and 85 years,
inclusive, or 18
and 85 years, i
nclusive, at ran
domization (de
pendent upon s
tudy stage)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992520
Page 135 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Male or female partic
ipants between the ag
es of 18 and 55 years,
inclusive, 65 and 85 y
ears, inclusive, or 18
and 85 years, inclusiv
e, at randomization (d
ependent upon study
stage)Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992521
Page 136 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.a Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
umb
er:2Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992522
Page 137 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n De
scri
ptio
n:Participants w
ho are willing
and able to co
mply with all s
cheduled visits
, vaccination pl
an, laboratory t
ests, lifestyle c
onsiderations,
and other study
procedures
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN02A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992523
Page 138 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participants who are
willing and able to co
mply with all schedul
ed visits, vaccination
plan, laboratory tests,
lifestyle consideratio
ns, and other study pr
oceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992524
Page 139 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:Healthy partici
pants who are
determined by
medical history
, physical exa
mination, and c
linical judgme
nt of the invest
igator to be eli
gible for inclus
ion in the study
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992525
Page 140 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN03A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992526
Page 141 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Healthy participants
who are determined b
y medical history, ph
ysical examination, a
nd clinical judgment
of the investigator to
be eligible for inclusi
on in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992527
Page 142 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Incl
usio
n N
umb
er:4
Crit
erio
n De
scri
ptio
n:Capable of giv
ing personal si
gned informed
consent, which
includes compl
iance with the
requirements a
nd restrictions
listed in the IC
D and in this p
rotocol
Crit
erio
n m
et?:YESInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992528
Page 143 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):IN04A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992529
Page 144 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Capable of giving per
sonal signed informe
d consent, which incl
udes compliance with
the requirements and
restrictions listed in t
he ICD and in this pr
otocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992530
Page 145 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n N
umb
er:1
Crit
erio
n De
scri
ptio
n:Other medical
or psychiatric c
ondition incl. r
ecent (within p
ast year) or acti
ve suicidal idea
tion/behavior/l
ab abnormality
that may increa
se the risk of st
udy participati
on
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992531
Page 146 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Other medical or psy
chiatric condition incl
. recent (within past y
ear) or active suicidal
ideation/behavior/lab
abnormality that may
increase the risk of st
udy participationInitial Entry
2.a Criterion met?
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992532
Page 147 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usion
Num
ber:2
Crite
rion
Desc
riptio
n:Known infecti
on with huma
n immunodefi
ciency virus (
HIV), hepatiti
s C virus (HC
V), or hepatiti
s B virus (HB
V)Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992533
Page 148 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crite
rion
met?
:NO
Crite
rion I
D: (F
or Pfi
zer u
se onl
y):EX02A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992534
Page 149 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Known infection with
human immunodefici
ency virus (HIV), hep
atitis C virus (HCV),
or hepatitis B virus (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992535
Page 150 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
2.c
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n De
scri
ptio
n:History of seve
re adverse reac
tion associated
with a vaccine
and/or severe a
llergic reaction
(eg, anaphylax
is) to any com
ponent of the s
tudy interventi
on(s)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992536
Page 151 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX03A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992537
Page 152 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
History of severe adv
erse reaction associat
ed with a vaccine and
/or severe allergic rea
ction (eg, anaphylaxis
) to any component of
the study intervention
(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992538
Page 153 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:4
Criterio
n Descr
iption:Receipt of
medication
s intended t
o prevent C
OVID-19
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX04A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992539
Page 154 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.d Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of medication
s intended to prevent
COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992540
Page 155 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:8
Crit
erio
n De
scrip
tion:Immunocompr
omised individ
uals with kno
wn or suspecte
d immunodefi
ciency, as dete
rmined by hist
ory and/or lab
oratory/physic
al examination
Crit
erio
n me
t?:NO
Crit
erio
n ID
: (Fo
r Pfi
zer u
se on
ly):EX08A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992541
Page 156 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Immunocompromised
individuals with kno
wn or suspected imm
unodeficiency, as dete
rmined by history and
/or laboratory/physica
l examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992542
Page 157 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:10
Crit
erio
n De
scri
ptio
n:Bleeding diath
esis or conditio
n associated wi
th prolonged bl
eeding that wo
uld, in the opin
ion of the inve
stigator, contra
indicate intram
uscular injecti
on
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992543
Page 158 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX10A00
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992544
Page 159 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or
condition associated
with prolonged bleedi
ng that would, in the
opinion of the investi
gator, contraindicate i
ntramuscular injectio
nInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992545
Page 160 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:11
Criterio
n Descri
ption:Women w
ho are pre
gnant or b
reastfeedi
ng
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX11A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992546
Page 161 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Women who are preg
nant or breastfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992547
Page 162 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:12
Criterio
n Descri
ption:Previous v
accination
with any c
oronavirus
vaccine
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX12A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992548
Page 163 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Previous vaccination
with any coronavirus
vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992549
Page 164 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:13
Crite
rion
Descr
iption
:Subjects who
receive immu
nosuppressive
therapy, such
as cytotoxic a
gents or syste
mic corticoste
roids
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX13A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992550
Page 165 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemi
c corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992551
Page 166 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
2.j
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:15
Crit
erio
n De
scrip
tion:Receipt of blo
od/plasma pro
ducts or immu
noglobulin, fro
m 60 days bef
ore study inter
vention admini
stration or plan
ned receipt thr
oughout the st
udy
Crit
erio
n me
t?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992552
Page 167 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX14A01
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992553
Page 168 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plas
ma products or immu
noglobulin, from 60 d
ays before study inter
vention administratio
n or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992554
Page 169 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992555
Page 170 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n Nu
mbe
r:16
Crite
rion
Desc
ripti
on:Participation i
n other studie
s involving st
udy interventi
on within 28
days prior to s
tudy entry and
/or during stu
dy participati
on
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX15A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992556
Page 171 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Participation in other
studies involving stu
dy intervention withi
n 28 days prior to stu
dy entry and/or durin
g study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992557
Page 172 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
2.l
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Exclu
sion
Num
ber:17
Crite
rion
Descr
iption
:Previous part
icipation in o
ther studies i
nvolving stu
dy interventi
on containin
g lipid nanop
articles
Crite
rion
met?:NO
Crite
rion I
D: (F
or Pfi
zer us
e only
):EX16A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992558
Page 173 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.l Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(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-17-2020
22:00:21
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992559
Page 174 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
2.m
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Excl
usio
n N
um
ber:22
Crit
erio
n D
escr
ipti
on:Investigator sit
e staff or Pfize
r employees di
rectly involved
in the conduct
of the study, sit
e staff otherwi
se supervised b
y the investigat
or, and their re
spective famil
y members
Crit
erio
n m
et?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992560
Page 175 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):EX21A01
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992561
Page 176 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Investigator site staff
or Pfizer employees
directly involved in t
he conduct of the stu
dy, site staff otherwis
e supervised by the i
nvestigator, and their
respective family me
mbersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992562
Page 177 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-17-2020
22:00:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992563
Page 178 of 326
***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: 12411197 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-17-2020
22:00:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020
22:00:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020
22:00:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992564
Page 179 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
109.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020
22:01:16ACV0PFEINFP6000 Data Entry:
170.0Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992565
Page 180 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Unit:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
37.7Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.5
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992566
Page 181 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020
22:01:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992567
Page 182 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-17-2020
22:01:25ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992568
Page 183 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-17-2020
22:01:25ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992569
Page 184 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
6.a Test:
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-17-2020
22:01:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992570
Page 185 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020
22:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020
22:01:38
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
53662Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992571
Page 186 of 326
***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: 12411197 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
07:19:58
(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
07:19:58
(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
07:20:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
07:19:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992572
Page 187 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Aug-18-2020
07:19:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
07:20:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP5RY
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020
07:20:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RYMInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020
07:20:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP5RY
NInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992573
Page 188 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Sample ID
Date Location User Value Reason
Aug-18-2020
07:20:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RYNInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020
07:20:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP5RY
PInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-18-2020
07:20:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RYPInitial Entry
5.d
Date Location User Value Reason
Aug-18-2020
07:20:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BLCH8
8Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992574
Page 189 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.d Sample ID
Date Location User Value Reason
Aug-18-2020
07:20:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BLCH88Initial Entry
5.e
Date Location User Value Reason
Aug-18-2020
07:20:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BLCH8
9Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020
07:20:49
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BLCH89Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992575
Page 190 of 326
***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: 12411197 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
07:21:06
(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
07:21:06
(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
07:21:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-18-2020
07:21:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992576
Page 191 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Aug-18-2020
07:21:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
07:21:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID
:BP5RX
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-18-2020
07:21:13
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BP5RX6Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992577
Page 192 of 326
***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: 12411197 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-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020
22:02:11
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Aug/17/2020 21:23Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992578
Page 193 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020
22:02:11
(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-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992579
Page 194 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-17-2020
22:02:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992580
Page 195 of 326
***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: 12411197 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-17-2020
22:02:17
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992581
Page 196 of 326
***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: 12411197 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-08-2020
17:46:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992582
Page 197 of 326
***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: 12411197 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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992583
Page 198 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
17:47:51
(UTC-03:00) City
of Buenos AiresFEVER
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992584
Page 199 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992585
Page 200 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
LInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992586
Page 201 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.d Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-08-2020
17:47:51ACV0PFEINFP6000 Data Entry:
Symptom:: VOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992587
Page 202 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos AiresMI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NO
2.e Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992588
Page 203 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992589
Page 204 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992590
Page 205 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.g Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE 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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992591
Page 206 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
2.h Symptom:
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED 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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) CityACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992592
Page 207 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
4. Injection Site Body Side:
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
17:47:51ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992593
Page 208 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992594
Page 209 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
17:47:51
(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-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992595
Page 210 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
17:47:51
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992596
Page 211 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020
17:48:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020
17:48:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:37.0
Temperatu
re Unit:C
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020
17:48:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992597
Page 212 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature:
Date Location User Value Reason
Sep-08-2020
17:48:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020
17:48:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020
17:48:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992598
Page 213 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020
17:48:25ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992599
Page 214 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020
17:48:25ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992600
Page 215 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City
of Buenos Aires
6.a Test:
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020
17:48:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992601
Page 216 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020
18:45:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020
18:45:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
18:46:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
18:45:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0992602
Page 217 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and correct as
appropriate.
Sep-08-2020
18:45:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020
18:46:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Sample I
D:BPX0N
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
18:46:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
BPX0NXInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992603
Page 218 of 326
***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: 12411197 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-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020
17:50:19
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Sep/8/2020 16:27Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992604
Page 219 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020
17:50:19
(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-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992605
Page 220 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-08-2020
17:50:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0992606
Page 221 of 326
***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: 12411197 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
16:45:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/7/2020Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992607
Page 222 of 326
***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: 12411197 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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-07-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0992608
Page 223 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
16:46:08
(UTC-03:00) City
of Buenos AiresFEVER
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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0992609
Page 224 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992610
Page 225 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992611
Page 226 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.d Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992612
Page 227 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992613
Page 228 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992614
Page 229 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE 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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) CityACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR WInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992615
Page 230 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
of Buenos Aires ORSE
NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED 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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0992616
Page 231 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992617
Page 232 of 326
***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: 12411197 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-07-2020
16:46:08
(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
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020
16:46:08
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3f3d\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0992618
Page 233 of 326
***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: 12411197 Subject Initials: ---
Gene
…[truncated]