125742 S1 M5 CRF c4591001 1241 12411643

Document text

Page 1 of 179
***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: 12411643 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
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996336
Page 2 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996337
Page 3 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411643]
2.Birth Date: 1962
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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996338
Page 4 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996339
Page 5 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996340
Page 6 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
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
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996341
Page 7 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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
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
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996342
Page 8 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996343
Page 9 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996344
Page 10 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carpal tunnel syndrome]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996345
Page 11 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [67.9]
3.Unit: kg
4.Height: [155.5]
5.Unit: cm
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996346
Page 12 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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/4/2020
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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996347
Page 13 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [252961]
3.Randomization Group: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996348
Page 14 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPX0LJ]
5.bSample ID [BPX0LK]
5.cSample ID [BPX0LL]
5.dSample ID [BLCTXL]
5.eSample ID [BLCTXM]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996349
Page 15 of 179
***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: 12411643 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/4/2020
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 [BPX0JR]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996350
Page 16 of 179
***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: 12411643 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/4/2020 18:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996351
Page 17 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996352
Page 18 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996353
Page 19 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996354
Page 20 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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/24/2020
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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996355
Page 21 of 179
***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: 12411643 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/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVYG7]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996356
Page 22 of 179
***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: 12411643 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/24/2020 09:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996357
Page 23 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996358
Page 24 of 179
***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: 12411643 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/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR73WN]
5.bSample ID [BS5BVD]
5.cSample ID [BS5BVF]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996359
Page 25 of 179
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996360
Page 26 of 179
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996361
Page 27 of 179
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996362
Page 28 of 179
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996363
Page 29 of 179
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996364
Page 30 of 179
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996365
Page 31 of 179
***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: 12411643 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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996366
Page 32 of 179
***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: 12411643 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: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996367
Page 33 of 179
***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: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996368
Page 34 of 179
***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: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996369
Page 35 of 179
***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: 12411643 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?
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996370
Page 36 of 179
***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: 12411643 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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996371
Page 37 of 179
***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: 12411643 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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996372
Page 38 of 179
***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: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996373
Page 39 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996374
Page 40 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996375
Page 41 of 179
***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: 12411643 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/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996376
Page 42 of 179
***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: 12411643 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: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996377
Page 43 of 179
***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: 12411643 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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996378
Page 44 of 179
***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: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996379
Page 45 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1. ADVERSE E
VENT 1  Acute cholecystit
is Oct/24/2020 U
NK:UNK NO
End Date Time:
Oct/28/2020 UNK:U
NK
 Repeating
Pages
 2. DELETED ADVERSE E
VENT 2  Hyperbilirubinem
ia Oct/24/2020 U
NK:UNK YES  Repeating
Pages
 3. DELETED ADVERSE E
VENT 3  Elevation of liver
enzymes Oct/24/2020 U
NK:UNK YES  Repeating
Pages
 4. ADVERSE E
VENT 4  Cholelithiasis  Oct/24/2020 U
NK:UNK NO
End Date Time:
Oct/28/2020 UNK:U
NK
 Repeating
Pages
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996380
Page 46 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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)[Acute cholecystitis]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996381
Page 47 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[gallstone]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020419104]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996382
Page 48 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hyperbilirubinemia ]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
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:
[Cholelithiasis ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996383
Page 49 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996384
Page 50 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Elevation of liver enzymes ]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
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:
[Cholelithiasis ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996385
Page 51 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996386
Page 52 of 179
***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: 12411643 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)[Cholelithiasis]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996387
Page 53 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Gallstone]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020419104]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996388
Page 54 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996389
Page 55 of 179
***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: 12411643 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[ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996390
Page 56 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996391
Page 57 of 179
***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: 12411643 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: //
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996392
Page 58 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996393
Page 59 of 179
***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: 12411643 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?
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996394
Page 60 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996395
Page 61 of 179
***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: 12411643 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?
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996396
Page 62 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996397
Page 63 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996398
Page 64 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996399
Page 65 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996400
Page 66 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996401
Page 67 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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?
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996402
Page 68 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996403
Page 69 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996404
Page 70 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996405
Page 71 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996406
Page 72 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996407
Page 73 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996408
Page 74 of 179
***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: 12411643 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
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996409
Page 75 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996410
Page 76 of 179
***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: 12411643 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
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996411
Page 77 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996412
Page 78 of 179
***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: 12411643 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: [ ]
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996413
Page 79 of 179
***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: 12411643 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/22/2020
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996414
Page 80 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996415
Page 81 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 Feb-04-2021 17:35:34 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996416
Page 82 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 Feb-04-2021 17:35:34 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-29-2021 10:39:51 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira  Approved Nov-17-2020 17:40:12 (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-17-2020 17:32:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996417
Page 83 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Edson Moreira  Approved Nov-17-2020 16:24:40 (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-17-2020 14:08:48 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-09-2020 08:25:27 (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 Nov-09-2020 08:19:00 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-30-2020 18:55:23 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996418
Page 84 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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 Oct-30-2020 18:27:39 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira  Approved Oct-30-2020 14:29:48 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-28-2020 16:43:02 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira  Approved Oct-26-2020 15:09:55 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996419
Page 85 of 179
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 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.
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996420
Page 86 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020 19:15:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020 19:15:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996421
Page 87 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 19:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/4/2020Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996422
Page 88 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020 19:15:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12411643Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 19:15:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1962Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020 19:16:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996423
Page 89 of 179
***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: 12411643 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-04-2020 19:16:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996424
Page 90 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participa
nts between the ages of 1
8 and 55 years, inclusive,
65 and 85 years, inclusiv
e, or 18 and 85 years, inc
lusive, at randomization
(dependent upon study st
age)
Criter
ion m
et?:YES
Criter
ion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Male or female participants betw
een the ages of 18 and 55 years, iInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996425
Page 91 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study stage)
1.a Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criter
ion De
scripti
on:Participants who are will
ing and able to comply
with all scheduled visits,
vaccination plan, laborat
ory tests, lifestyle consid
erations, and other study
procedures
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996426
Page 92 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participants who are willing and
able to comply with all scheduled
visits, vaccination plan, laborator
y tests, lifestyle considerations, a
nd other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclus
ion Nu
mber:3Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996427
Page 93 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Healthy participants wh
o are determined by med
ical history, physical exa
mination, and clinical ju
dgment of the investigat
or to be eligible for inclu
sion in the study
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996428
Page 94 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Inclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Healthy participants who are dete
rmined by medical history, physi
cal examination, and clinical jud
gment of the investigator to be eli
gible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996429
Page 95 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Capable of giving perso
nal signed informed con
sent, which includes co
mpliance with the requir
ements and restrictions l
isted in the ICD and in t
his protocol
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996430
Page 96 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Inclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Capable of giving personal signe
d informed consent, which includ
es compliance with the requireme
nts and restrictions listed in the I
CD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996431
Page 97 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criter
ion De
scripti
on:Other medical or psychia
tric condition incl. recent
(within past year) or acti
ve suicidal ideation/beha
vior/lab abnormality that
may increase the risk of
study participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Other medical or psychiatric con
dition incl. recent (within past ye
ar) or active suicidal ideation/beh
avior/lab abnormality that may in
crease the risk of study participat
ionInitial Entry
2.a Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996432
Page 98 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descri
ption:Known infection with
human immunodeficie
ncy virus (HIV), hepati
tis C virus (HCV), or h
epatitis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996433
Page 99 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Known infection with human im
munodeficiency virus (HIV), hep
atitis C virus (HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996434
Page 100 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Des
criptio
n:History of severe advers
e reaction associated wit
h a vaccine and/or sever
e allergic reaction (eg, a
naphylaxis) to any comp
onent of the study interv
ention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996435
Page 101 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.c Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
History of severe adverse reactio
n associated with a vaccine and/o
r severe allergic reaction (eg, ana
phylaxis) to any component of th
e study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medica
tions intended to p
revent COVID-19
Criterion m
et?:NOInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996436
Page 102 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of medications intended t
o prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:8Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996437
Page 103 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Des
criptio
n:Immunocompromised i
ndividuals with known
or suspected immunode
ficiency, as determined
by history and/or labora
tory/physical examinati
on
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996438
Page 104 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.e Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Immunocompromised individual
s with known or suspected immu
nodeficiency, as determined by hi
story and/or laboratory/physical e
xaminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996439
Page 105 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Des
criptio
n:Bleeding diathesis or co
ndition associated with
prolonged bleeding that
would, in the opinion of
the investigator, contrai
ndicate intramuscular in
jection
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996440
Page 106 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.f Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition a
ssociated with prolonged bleedin
g that would, in the opinion of th
e investigator, contraindicate intr
amuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeeding
Criterion met
?:NOInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996441
Page 107 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Women who are pregnant or brea
stfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusion N
umber:12
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccineInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996442
Page 108 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous vaccination with any co
ronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996443
Page 109 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive th
erapy, such as cytotoxi
c agents or systemic c
orticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxi
c agents or systemic corticosteroi
dsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996444
Page 110 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglo
bulin, from 60 days befo
re study intervention ad
ministration or planned
receipt throughout the st
udy
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996445
Page 111 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 day
s before study intervention admin
istration or planned receipt throu
ghout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996446
Page 112 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study i
ntervention within 28 d
ays prior to study entry
and/or during study par
ticipation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX15A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996447
Page 113 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participation in other studies inv
olving study intervention within
28 days prior to study entry and/
or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996448
Page 114 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descri
ption:Previous participation
in other studies invol
ving study interventio
n containing lipid nan
oparticles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Previous participation in other st
udies involving study interventio
n containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996449
Page 115 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees directl
y involved in the conduc
t of the study, site staff o
therwise supervised by t
he investigator, and their
respective family memb
ers
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996450
Page 116 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.m Exclusion Number:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in th
e conduct of the study, site staff
otherwise supervised by the inve
stigator, and their respective fam
ily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-04-2020 19:16:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996451
Page 117 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020 19:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020 19:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020 19:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996452
Page 118 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:Carpal tunnel sy
ndrome
Start Date: UNK/UNK/201
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Carpal tunnel syndromeInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020 19:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996453
Page 119 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
67.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
155.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City ofACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.1Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996454
Page 120 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
7.a
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 37.5
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
37.5Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 19:18:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996455
Page 121 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996456
Page 122 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 19:18:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996457
Page 123 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020 19:19:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020 19:19:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
252961Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996458
Page 124 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 20:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 20:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 20:18:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 20:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 20:18:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 20:18:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPX0LJInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996459
Page 125 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 20:18:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPX0LJInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 20:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPX0LKInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-04-2020 20:18:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPX0LKInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 20:19:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPX0LLInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-04-2020 20:19:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPX0LLInitial Entry
5.d
Date Location User Value Reason
Sep-04-2020 20:21:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCTXLInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996460
Page 126 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.d Sample ID
Date Location User Value Reason
Sep-04-2020 20:21:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTXLInitial Entry
5.e
Date Location User Value Reason
Sep-04-2020 20:21:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLCTXMInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-04-2020 20:21:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLCTXMInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996461
Page 127 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 20:13:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 20:13:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 20:14:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 20:13:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 20:13:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 20:14:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPX0JRInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996462
Page 128 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 20:14:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPX0JRInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996463
Page 129 of 179
***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: 12411643 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-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/4/2020 18:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020 19:19:34
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996464
Page 130 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
7. Route:
Date Location User Value Reason
Sep-04-2020 19:19:34
(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-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 19:19:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996465
Page 131 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 19:19:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996466
Page 132 of 179
***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: 12411643 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-24-2020 10:15:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996467
Page 133 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 10:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 10:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 37.1
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 10:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 10:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
37.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 10:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996468
Page 134 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 10:16:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996469
Page 135 of 179
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996470
Page 136 of 179
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-24-2020 10:16:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996471
Page 137 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 08:01:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 08:01:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 08:02:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 08:01:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 08:01:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 08:02:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPVYG7Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996472
Page 138 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 08:02:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPVYG7Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996473
Page 139 of 179
***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: 12411643 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-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/24/2020 09:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-24-2020 10:16:45
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996474
Page 140 of 179
***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: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
7. Route:
Date Location User Value Reason
Sep-24-2020 10:16:45
(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-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-24-2020 10:16:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996475
Page 141 of 179
***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: 12411643 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-22-2020 11:00:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996476
Page 142 of 179
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 09:27:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 09:27:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 09:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 09:27:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-23-2020 09:27:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 09:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR73WNInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996477
Page 143 of 179
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 09:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR73WNInitial Entry
5.b
Date Location User Value Reason
Oct-23-2020 09:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS5BVDInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 09:29:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS5BVDInitial Entry
5.c
Date Location User Value Reason
Oct-23-2020 09:29:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS5BVFInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 09:29:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS5BVFInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996478
Page 144 of 179
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996479
Page 145 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996480
Page 146 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-09-2020 08:23:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996481
Page 147 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-09-2020 08:24:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996482
Page 148 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996483
Page 149 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Nov-17-2020
16:48:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Clo
sedUpdated
Nov-17-2020
14:08:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dNew Information
Nov-17-2020
14:08:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Acute
cholec
ystitisNew Information
Nov-17-2020
10:01:36
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dSAE RECON 1: The term
Cholelithiasis was recorded
as a separate event in SDB
based on coding
convention. Please consider
to split the term as separate
events to facilitate coding
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996484
Page 150 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and match Safety database.
Nov-15-2020
04:20:26
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Rei
ssued:
Candi
dateFor Clinical review
Nov-14-2020
14:09:15
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: An
swere
dThe data is correct. Please
consider what has been
defined by SI.
Nov-14-2020
13:45:05
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
2: Op
enedSAE
RECON:AER#2020419104,
the term was reported as
Acute cholecystitis with
cholelithiasis'. Please
consider to split the term as
separate events to facilitate
coding and match Safety
database.
Nov-09-2020
08:19:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Acute
cholec
ystitis
with c
holelit
hiasisNew Information
Oct-29-2020
11:39:27
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Oct-29-2020
09:12:57
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Oct-29-2020
09:12:57ACV0PFEINFP6000  Data
EntryTranscription Error
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996485
Page 151 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00)
City of
Buenos Aires:
Chole
lithias
is
Oct-29-2020
00:58:53
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify COLELITHIASIS
as follow... this term
appears to be misspelled.
Are you reporting
CHOLECYSTITIS? If so,
please edit it to such.
Otherwise, please edit or
further clarify. Thank you.
Oct-28-2020
16:43:02
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Coleli
thiasisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 08:19:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/28/2020 UNK:UNKTranscription Error
Nov-04-2020 16:49:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 11:33:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered we have not received
any new information
about the event. as
soon as possible we
will update the eCRF
and SAE.
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996486
Page 152 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-03-2020 14:42:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY-AE
"cholelithiasis" is on
going since Oct 24 :
Please review if
event remains
ongoing. Else, report
end date and update
event outcome status.
thank you
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 16:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-09-2020 18:43:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response satisfies
query
Nov-09-2020 08:21:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered the subject not
performed COVID
test during
hospitalization. SAE
FU report was sent
to safety on
07nov2020.
Nov-09-2020 06:31:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened Response does not
satisfy query
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996487
Page 153 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-06-2020 17:31:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Reissued:Candidate Response does not
satisfy query
Nov-05-2020 16:57:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered we will check if the
subject performed
covid test during
hospitalization. If is
applicable data will
be insert asap.
Nov-04-2020 22:33:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened Clinical - per Data
Monitoring
Committee, each
hospitalized subject
requires a report of
COVID test status.
If test performed =
YES/No/Not
available (in any
case), kindly
provide FU report
with results/status.
Thank you.
Oct-29-2020 08:04:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Colelithiasis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result in
death?Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996488
Page 154 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabi
lity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-09-2020
08:22:29
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data Entr
y:
NOT REL
ATED
If Not Re
lated to s
tudy trea
tment(s),
this even
t is due tTranscription
Error
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0996489
Page 155 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
o:
OTHE
R
If Oth
er, sp
ecify:
galls
tone
Nov-02-2020
07:41:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
ClosedResponse
satisfies query.
Oct-30-2020
18:27:39
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Oct-30-2020
18:27:39
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data Entr
y:
NOT REL
ATED
If Not Re
lated to s
tudy trea
tment(s),
this even
t is due t
o:
OTHE
R
If Oth
er, sp
ecify:
unk
now
nTranscription
Error
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0996490
Page 156 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-30-2020
16:23:05
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
Reissued:
OpenedAny
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. Please
review and
update as
necessary
Oct-30-2020
07:24:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
AnsweredAccording to
SI Gallstone is
the etiology of
Colelithiasis
Oct-29-2020
09:55:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field
[Gallstone].
Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. Please
review and
update as
necessary.
Oct-28-2020
16:58:31
(UTC-03:00)
City ofACV0PFEINFP6000  Data Entr
y:
NOT REL
ATEDTranscription
Error
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996491
Page 157 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires If Not Re
lated to s
tudy trea
tment(s),
this even
t is due t
o:
OTHE
R
If Oth
er, sp
ecify:
Gall
ston
e
Oct-28-2020
16:43:02
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data Entr
y:
NOT REL
ATED
If Not Re
lated to s
tudy trea
tment(s),
this even
t is due t
o:
OTHE
RInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 16:43:02 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996492
Page 158 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresYES
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-09-2020 08:22:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-09-2020 08:22:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDTranscription Error
Nov-09-2020 08:19:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Acute
cholecystitis with
cholelithiasis:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-30-2020 08:14:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-29-2020 09:13:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-29-2020 09:13:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RES
OLVEDTranscription Error
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0996493
Page 159 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020
08:05:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER2020419104,outcome
was reported as NOT
RECOVERED/NOT RESOLVED
to Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-28-2020
16:43:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 16:43:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 08:04:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2020419104Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996494
Page 160 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-30-2020 16:43:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Thank you.
Oct-30-2020 07:31:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered This will be
evaluated when
available.
Oct-29-2020 21:18:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Lab abnormalities
have been reported
on CRF, this
information is
missing on SAE
report. Please
consider a FU for
SAE narrative with
missing lab results
during
hospitalization when
available. Thank
you.
Oct-28-2020 16:47:36 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996495
Page 161 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-03:00) City of
Buenos AiresHyperbilirubinemia
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 16:49:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 11:32:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered we have not received
any new information
about the event. as
soon as possible we
will update the eCRF
and SAE.
Nov-03-2020 14:41:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY-AE
"hyperbilirubinemia"
is on going since Oct
24 : Please review if
event remains
ongoing. Else, report
end date and update
event outcome status.
thank you
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996496
Page 162 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 16:59:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 13:23:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-29-2020 13:11:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-29-2020 13:11:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
CholelithiasisTranscription Error
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996497
Page 163 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-29-2020 13:09:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Please verify if the
term is misspelled
and correct to
Cholelithiasis, if
necessary.
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
ColelithiasisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 16:47:36 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996498
Page 164 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-03:00) City of
Buenos AiresRECOVERING/RESOLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 16:47:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0996499
Page 165 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-09-2020 09:13:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response satisfies
query
Nov-09-2020 08:24:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Nov-09-2020 05:40:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened Response does not
satisfy query
Nov-06-2020 17:31:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Reissued:Candidate Response does not
satisfy query
Nov-05-2020 16:58:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered data will be update
asap.thanks!
Nov-04-2020 22:50:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Reissued:Opened Per case narrative,
"The subject was
admitted to the
hospital emergency
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996500
Page 166 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
on 24Oct2020 with
discreet abnormal
pain, fever, jaundice
and dark urine."
PLease clarify.
Thank you.
Nov-03-2020 13:24:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered There was no fever
during
hospitalization.
Nov-02-2020 17:05:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed resolved
Nov-01-2020 22:13:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened In case narrative
reported to safety,
the subject required
antibiotic, had ELE
and fever during
hospitalization.
Kindly clarify fever
workup and provide
update/clarify
underlying diagnosis
or if Cholecystitis
was considered.
Please submit FU
report.
Oct-30-2020 10:41:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Transaminases and
canalicular are liver
enzymes
Oct-29-2020 13:22:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened According to the
patient chart, AE is
Elevation of
transaminases and
canalicular, please
review and correct if
necessary
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Elevation of liver enzymesInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996501
Page 167 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 16:50:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 11:33:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered we have not received
any new information
about the event. as
soon as possible we
will update the eCRF
and SAE.
Nov-03-2020 14:39:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINQUERY-AE
"elevation liver
enzymes" is on going
since Oct 24 : Please
review if event
remains ongoing.
Else, report end date
and update event
outcome status.
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996502
Page 168 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-28-2020 16:59:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 13:23:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-29-2020 13:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-29-2020 13:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
CholelithiasisTranscription Error
Oct-29-2020 13:10:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Please verify if the
term is misspelled
and correct to
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996503
Page 169 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
Cholelithiasis, if
necessary.
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
ColelithiasisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996504
Page 170 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
*** THIS REPEATING FORM HAS BEEN DELETED ***
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 16:49:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996505
Page 171 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CholelithiasisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/28/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996506
Page 172 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-17-2020 17:32:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Cholelithiasis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabiliInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996507
Page 173 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
GallstoneInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996508
Page 174 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-17-2020 14:10:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-17-2020 17:32:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2020419104Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0996509
Page 175 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 10:40:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0996510
Page 176 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-29-2021 10:40:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0996511
Page 177 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-29-2021 10:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/21/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021 10:39:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0996512
Page 178 of 179
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020 19:19:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-04-2020 19:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Sep-04-2020 19:19:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-04-2020 19:17:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
FDA-CBER-2021-5683-0996513
Page 179 of 179
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411643 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 15:09:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Edson
MoreiraData Entry:
Click Here to EnableInitial Entry
090177e196ae3f4b\Final\Final On: 01-Apr-2021 05:15 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0996514