125742 S1 M5 CRF c4591001 1231 12314407

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
178
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Document text

Page 1 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883333
Page 2 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883334
Page 3 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314407]
2.Birth Date: /1994
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883335
Page 4 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883336
Page 5 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883337
Page 6 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883338
Page 7 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Dengue]
Start Date: Apr/15/2020
Ongoing: NO
End Date:
May/1/2020
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883339
Page 8 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [64.0]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [23.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883340
Page 9 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
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:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883341
Page 10 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [69574]
3.Randomization Group: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883342
Page 11 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BPTGK4]
5.bSample ID [BPTGK5]
5.cSample ID [BPTGK6]
5.dSample ID [BLBJTM]
5.eSample ID [BLBJTN]
5 fSample ID [BLBJTP]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883343
Page 12 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BPTF6X]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883344
Page 13 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 11:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883345
Page 14 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883346
Page 15 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883347
Page 16 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883348
Page 17 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/16/2020
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:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883349
Page 18 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BP2BF1]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883350
Page 19 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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/16/2020 14:20
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
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883351
Page 20 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883352
Page 21 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
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 [BNTR33]
5.bSample ID [BJ4F7S]
5.cSample ID [BP1PFV]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883353
Page 22 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883354
Page 23 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883355
Page 24 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883356
Page 25 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883357
Page 26 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883358
Page 27 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883359
Page 28 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883360
Page 29 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883361
Page 30 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883362
Page 31 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883363
Page 32 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883364
Page 33 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883365
Page 34 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883366
Page 35 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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 [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883367
Page 36 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883368
Page 37 of 178
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883369
Page 38 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883370
Page 39 of 178
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883371
Page 40 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883372
Page 41 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883373
Page 42 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883374
Page 43 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883375
Page 44 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883376
Page 45 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/21/2021
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883377
Page 46 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883378
Page 47 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/21/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883379
Page 48 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/21/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883380
Page 49 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRZ4CK]
5.bSample ID [BRZ4D5]
5.cSample ID [BPWF72]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883381
Page 50 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPWBLG]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883382
Page 51 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/21/2021 10:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883383
Page 52 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883384
Page 53 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/11/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883385
Page 54 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHXH6G]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883386
Page 55 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/11/2021 16:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883387
Page 56 of 178
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883388
Page 57 of 178
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883389
Page 58 of 178
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883390
Page 59 of 178
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883391
Page 60 of 178
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883392
Page 61 of 178
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883393
Page 62 of 178
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883394
Page 63 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1. ADVERSE EVE
NT 1  Polytrauma  Sep/20/2020 19
:30 NO
End Date Time:
Dec/21/2020 19:00
 Repeating
Pages
 2. ADVERSE EVE
NT 2  Epistaxis  Sep/20/2020 19
:30 NO
End Date Time:
Oct/19/2020 22:00
 Repeating
Pages
 3. DELETED ADVERSE EVE
NT 3  Epistaxis  Sep/20/2020 19
:30 YES  Repeating
Pages
 4. ADVERSE EVE
NT 4  subgaleal hemat
oma Sep/20/2020 19
:30 NO
End Date Time:
Nov/9/2020 09:30
 Repeating
Pages
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883395
Page 64 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[Polytrauma]
4.Start Date Time: Sep/20/2020 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/21/2020 19:00
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?
YES
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
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:
[Hit by a vehicle]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883396
Page 65 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?: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[2020402387]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883397
Page 66 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[Epistaxis]
4.Start Date Time: Sep/20/2020 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 22:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[sphenoid fracture]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883398
Page 67 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883399
Page 68 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** 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)[Epistaxis]
4.Start Date Time: Sep/20/2020 19:30
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Car crash ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883400
Page 69 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT 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[ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883401
Page 70 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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)[subgaleal hematoma]
4.Start Date Time: Sep/20/2020 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 09:30
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[road accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883402
Page 71 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883403
Page 72 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883404
Page 73 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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[ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883405
Page 74 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883406
Page 75 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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: //
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883407
Page 76 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883408
Page 77 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883409
Page 78 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883410
Page 79 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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?
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883411
Page 80 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883412
Page 81 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883413
Page 82 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883414
Page 83 of 178
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883415
Page 84 of 178
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883416
Page 85 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883417
Page 86 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883418
Page 87 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina Rivera  Approved Mar-16-2021 16:59:25 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, 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.
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883419
Page 88 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-27-2020 13:25:53 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883420
Page 89 of 178
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormJan-21-2021 12:24:59 (UTC-03:00) City of Buenos
AiresMartina Davalli Not Applicable
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883421
Page 90 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Yanina Rivera  Approved Mar-16-2021 16:59:25 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, YaninaRivera, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-11-2021 14:08:20 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-16-2021 13:01:33 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-11-2021 16:44:28 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-22-2021 15:27:35 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0883422
Page 91 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
Martina Davalli  N/A Jan-21-2021 12:24:03 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 08:58:29 (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 Dec-25-2020 20:24:13 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-25-2020 18:19:04 (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.
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883423
Page 92 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Maria Beretta  N/A Nov-25-2020 09:34:11 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 18:54:44 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 11:57:24 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-08-2020 16:50:47 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, SantiagoCorradetti, 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-07-2020 11:03:49 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-06-2020 14:30:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883424
Page 93 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883425
Page 94 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 13:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-27-2020 13:24:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883426
Page 95 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 13:25:06
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883427
Page 96 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 09:53:17
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314407Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 09:53:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1994Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 13:24:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 13:24:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-27-2020 13:24:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883428
Page 97 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 13:25:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883429
Page 98 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 13:26:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 13:26:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 13:26:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883430
Page 99 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 13:27:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:Dengue
Start Date: Apr/15/2020
Ongoing: NO
End Date:
May/1/202
0Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 13:27:07
(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
Aug-27-2020 13:27:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
DengueInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 13:27:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Apr/15/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 13:27:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
May/1/2020Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883431
Page 100 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
64.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.5Initial Entry
7.a
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883432
Page 101 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 13:28:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883433
Page 102 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883434
Page 103 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020 13:28:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883435
Page 104 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 13:28:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 13:28:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
69574Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883436
Page 105 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 13:29:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 13:29:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 14:36:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 02:23:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-27-2020 13:29:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-27-2020 13:29:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 14:36:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTGK4Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883437
Page 106 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 14:36:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTGK4Initial Entry
5.b
Date Location User Value Reason
Aug-28-2020 14:36:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTGK5Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 14:36:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTGK5Initial Entry
5.c
Date Location User Value Reason
Aug-28-2020 14:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTGK6Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 14:36:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTGK6Initial Entry
5.d
Date Location User Value Reason
Aug-28-2020 18:48:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJTMInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883438
Page 107 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 18:48:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJTMInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020 18:48:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJTNInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 18:48:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJTNInitial Entry
5.f
Date Location User Value Reason
Aug-28-2020 18:48:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BLBJTPInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-28-2020 18:48:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BLBJTPInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883439
Page 108 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 13:29:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 13:29:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 15:06:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 02:23:48
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-27-2020 13:29:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-27-2020 13:29:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 15:06:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTF6XInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883440
Page 109 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 15:06:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTF6XInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883441
Page 110 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Aug/27/2020 11:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883442
Page 111 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-27-2020 13:29:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883443
Page 112 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-27-2020 13:29:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883444
Page 113 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020 11:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-29-2020 09:38:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The participant has
not yet made the third
visit.
Oct-28-2020 12:42:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if subject has
returned for
V3PostVAX2. If yes,
please complete
V3PostVAX2 record
and EOT record.
Sep-18-2020 12:58:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883445
Page 114 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 12:59:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 12:59:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 12:59:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 12:59:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 12:59:01
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 12:59:01
(UTC-03:00) City of BuenosACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883446
Page 115 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883447
Page 116 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883448
Page 117 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 12:59:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883449
Page 118 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 17:01:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 17:01:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 17:01:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 17:01:13
(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-16-2020 17:01:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 17:01:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP2BF1Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883450
Page 119 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-16-2020 17:01:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP2BF1Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883451
Page 120 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020 14:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883452
Page 121 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Sep-18-2020 12:59:21
(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-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-18-2020 12:59:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883453
Page 122 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-13-2020
12:59:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-13-2020
09:45:46
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query
1: Ans
weredThe visit is out of windows
because the subject suffered a
Motor Vehicle Accident and
was unable to attend
previously
Nov-13-2020
07:21:01
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 22 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Nov-12-2020
11:57:24
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data
Entry
:
Nov/1
2/202
0Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883454
Page 123 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 11:57:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 11:57:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 13:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-12-2020 13:39:44
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-12-2020 11:57:37
(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.
Nov-12-2020 11:57:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 13:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNTR33Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883455
Page 124 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 13:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNTR33Initial Entry
5.b
Date Location User Value Reason
Nov-12-2020 16:34:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sample ID: BJ4F7SInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-12-2020 16:34:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
BJ4F7SInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020 16:47:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP1PFVInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-12-2020 16:47:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1PFVInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883456
Page 125 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 11:57:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020 11:57:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 11:57:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883457
Page 126 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-15-2021 13:07:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/14/2021Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883458
Page 127 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-15-2021 13:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-15-2021 13:07:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-15-2021 13:07:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible per local/national recomm
endations and confirmed to have r
eceived only placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883459
Page 128 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021 12:24:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/21/2021Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883460
Page 129 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-21-2021 12:24:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtained
Jan/21/2021Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883461
Page 130 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-21-2021 12:25:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/21/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-21-2021 12:25:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-21-2021 12:25:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883462
Page 131 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/21/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883463
Page 132 of 178
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-21-2021 12:25:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NEGATIVEInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883464
Page 133 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 12:25:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 12:25:45
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 09:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-21-2021 12:52:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-21-2021 12:25:45
(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.
Jan-21-2021 12:25:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021 09:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRZ4CKInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883465
Page 134 of 178
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Jan-22-2021 09:06:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRZ4CKInitial Entry
5.b
Date Location User Value Reason
Jan-22-2021 10:30:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRZ4D5Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-22-2021 10:30:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRZ4D5Initial Entry
5.c
Date Location User Value Reason
Jan-22-2021 13:59:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWF72Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-22-2021 13:59:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWF72Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883466
Page 135 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-21-2021 12:26:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-21-2021 12:26:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 10:43:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-21-2021 12:52:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-21-2021 12:26:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-21-2021 12:26:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Jan/21/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021 10:43:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWBLGInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883467
Page 136 of 178
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Jan-22-2021 10:43:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWBLGInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883468
Page 137 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/21/2021 10:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883469
Page 138 of 178
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Jan-21-2021 12:26:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883470
Page 139 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021 16:44:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/11/2021Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883471
Page 140 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/11/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883472
Page 141 of 178
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-11-2021 16:44:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883473
Page 142 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-11-2021 16:44:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-11-2021 16:44:58
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-12-2021 10:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-12-2021 06:59:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Feb-11-2021 16:44:58
(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.
Feb-11-2021 16:44:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/11/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883474
Page 143 of 178
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Feb-12-2021 10:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BHXH6GInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-12-2021 10:22:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BHXH6GInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883475
Page 144 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/11/2021 16:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883476
Page 145 of 178
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-11-2021 16:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883477
Page 146 of 178
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 15:42:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-12-2021 12:26:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered EOT2 updated
Mar-12-2021 11:19:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the 1-month
post vaccination visit
after the Vaccination
4. Please complete
treatment disposition
CRF and update date
of EOT2 to match
date of visit at visit
103.
Mar-11-2021 14:08:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/11/2021Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883478
Page 147 of 178
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-11-2021 14:08:36
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-12-2021 12:33:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-12-2021 09:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Mar-12-2021 09:32:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/11/2021New Information
Mar-12-2021 06:07:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Please update
date of contact. Thank
you.
Mar-11-2021 14:08:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883479
Page 148 of 178
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-12-2021 12:25:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021 12:25:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021 12:25:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883480
Page 149 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883481
Page 150 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883482
Page 151 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-22-2020 10:46:26
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Deleted The AE is
duplicated.
Thank you.
Oct-20-2020 18:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883483
Page 152 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Form Created
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883484
Page 153 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-15-2020 11:27:02
(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 Value Reason
Nov-07-2020 16:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Charu
SabharwalQuery 4: Closed Response satisfies
query
Nov-07-2020 11:38:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 4: Answered Subgaleal hematoma is
reported.
Nov-06-2020 19:51:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Charu
SabharwalQuery 4: Opened Please review the event
"Right
frontoparietotemporal
subgaleal hematoma"
for adverse event
reporting.
Nov-05-2020 15:49:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-05-2020 15:44:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-04-2020 19:09:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
Nov-04-2020 19:09:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PolytraumaNew Information
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883485
Page 154 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-03-2020 19:56:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened Clinical - SAE report
states additional
fractures detected in
Temporal and sphenoid
bones; please include
these additional fracture
events.
Oct-30-2020 11:32:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered Right
frontoparietotemporal
subgaleal hematoma is
associated to an
accident on public
roads
Oct-29-2020 14:38:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened Clinical Per Protocol
sections 10.3.1 and
10.3.3, all non-serious
AEs are recorded on the
AE CRF, and are
defined as ‘any
untoward medical
occurrence temporally
associated with drug
administration’ (to V3
for AEs).
Oct-29-2020 10:19:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered Right
frontoparietotemporal
subgaleal hematoma is
trauma secondary to an
accident on public
roads.
Oct-23-2020 15:42:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical On review of
the SAE report for
vertebral fractures, an
event of sub-galeal
hematoma has been
mentioned, yet it does
not appear in the CRF.
Please review for safety
and update AE log CRF
as appropriate.
Oct-23-2020 15:31:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-20-2020 11:16:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883486
Page 155 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-20-2020 11:16:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Traumatic vertebral fractures in C2,
T3, T4 and T5Changed Information
Oct-19-2020 10:59:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clinical - SAE
information reports
fractured vertebrae C2,
T3, T4 and T5. Please
update fracture(S) and
locations for this event.
Oct-15-2020 11:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Traumatic vertebral fractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/20/2020 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-25-2020 20:24:13
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/21/2020 19:00New Information
Oct-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020 11:27:02
(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).
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883487
Page 156 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Nov-03-2020 02:12:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Query closed; will
follow for SAE update
with the requested
COVID test info
Nov-02-2020 19:26:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Mabel Berrueta Query 2: Answered Sure. We are sending a
notification to the
follow up team to be
updated in SAE form.
Oct-30-2020 22:43:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Reissued:Opened Clinical – Thank you.
If NO hospital Covid
test was performed is
known, please submit
this information on a
follow-up SAE form,
as pertinent
information for this
trial.
Oct-30-2020 11:24:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered No test was performed
for Covid because the
adverse event is not
associated with Covid
disease, in addition the
patient did not present
symptoms of Covid
disease. SAE follow-up
form is sent.
Oct-23-2020 15:31:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical COVID testing
has not been reported
in the SAE submitted
to safety. Please submit
a follow-up SAE form
[#2020402387] to
provide whether
COVID testing was
performed (yes/no) and
if yes, the results.
Oct-17-2020 09:35:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 07:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:Traumatic
vertebral
fracture(Onset
date:20Sep2020) is not
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883488
Page 157 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-15-2020 11:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Traumatic
vertebral fracture:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-15-2020 11:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or pr
olong hospitalization?
YES
Did this serious event result in per
sistent or significant disability/inc
apacity?
YES
Is this serious event life threatenin
g?
NO
Other medically important serious
event
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883489
Page 158 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-20-2020 11:38:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-20-2020 10:59:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-20-2020 10:59:49
(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:
Hit by a vehicleNew Information
Oct-19-2020 13:41:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened According to site
response, the subject
was hit by a vehicle.
Please consider
updating 'If Other,
specify' field to
clarify that the
subject was hit by a
vehicle.
Oct-19-2020 13:39:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Site response
confirmed that
subject was not the
driver of the car, but
that subject was
actually hit by the car.
Oct-19-2020 10:58:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical - Please enter
the Motor Vehicle
Accident as an AE if
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883490
Page 159 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
the subject was the
driver of either
vehicle (see new
Protocol v8 CRF
completion guidelines
Sect 8.50.2.1); no
event required if she
was a passenger.
Oct-18-2020 12:46:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered no, the participant
was hit by a vehicle
Oct-16-2020 16:02:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if participant
was the driver of the
vehicle. If yes, please
enter Motor Vehicle
Accident as an AE on
the AE record. Please
see CRF Completion
Instructions Section
8.47.2.1.
Oct-15-2020 11:27:02
(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:
Car crashInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-15-2020 11:27:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883491
Page 160 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-15-2020 11:27:02
(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
Dec-25-2020 20:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-25-2020 20:24:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-25-2020 20:24:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Polytrauma:
Response to "What was
the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-18-2020 21:25:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-18-2020 13:04:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883492
Page 161 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-18-2020 13:04:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVIN
GChanged Information
Oct-17-2020 09:39:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020402387,outcome
was reported as
RECOVERING/RESOLVING to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Oct-15-2020 11:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT R
ESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-15-2020 11:27:02
(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-17-2020 09:35:00
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2020402387Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883493
Page 162 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-16-2020 12:17:14
(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-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
EpistaxisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/20/2020 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 14:25:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/19/2020 22:00New Information
Oct-29-2020 11:08:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883494
Page 163 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-29-2020 09:41:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The epistaxis
continues, pending
consultation with a
specialist.
Oct-28-2020 12:39:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if AE is
ONGOING (start date
20 Sep 2020)or
RESOLVED. If
RESOLVED, please
update AE record
accordingly and enter
END date.
Oct-16-2020 12:17:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-16-2020 12:17:14
(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-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883495
Page 164 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-04-2020
14:26:24
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATE
D
If Not Related
to study treatm
ent(s), this eve
nt is due to:
OTHER
If Other, sp
ecify:
sphenoid f
ractureNew
Information
Oct-22-2020
11:04:13
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-20-2020
11:02:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redNew
Information
Oct-20-2020
11:02:15
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATE
D
If Not Related
to study treatm
ent(s), this eve
nt is due to:
OTHER
If Other, sp
ecify:
Hit by a v
ehicleNew
Information
Oct-19-2020
18:39:18
(UTC-03:00)
City of BuenosACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Opene
dPlease review
"If not related to
study treatment
other" field, the
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883496
Page 165 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires following text
was indicated in
the comment
field [Car
crash]. Any
symptoms, AEs
or other key data
should be
collected on the
adverse event or
Medical history
page. Please
review and
update as
necessary.
Oct-16-2020
12:17:14
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATE
D
If Not Related
to study treatm
ent(s), this eve
nt is due to:
OTHER
If Other, sp
ecify:
Car crashInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883497
Page 166 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 12:17:14
(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
Nov-04-2020 14:27:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-04-2020 14:27:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-04-2020 14:25:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Epistaxis:
Response to "What
was the outcome of
this adverse event?" is
'Not Recovered/Not
Resolved' but AE End
Date/Time is present.
Oct-16-2020 12:17:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 12:17:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0883498
Page 167 of 178
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-20-2020 18:59:25
(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
Oct-22-2020 15:22:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-22-2020 13:21:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Candidate Response does not
satisfy query
Oct-22-2020 10:46:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered The AE is duplicated.
Thank you.
Oct-21-2020 12:03:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: There are
2 AEs of Epistaxis
with same start and
stop dates. Please
confirm if duplicate
entry. If duplicate
entry, please update
AE record.
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
EpistaxisInitial Entry
4. Start Date Time:
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0883499
Page 168 of 178
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/20/2020 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-20-2020 18:59:25
(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-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883500
Page 169 of 178
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-24-2020
04:10:38
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Sandip Namdeorao
SuryawanshiQuery 1: Closed Response
satisfies query
Oct-22-2020
10:46:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redThe AE is
duplicated.
Thank you.
Oct-21-2020
07:58:04
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Opene
dPlease review
"If not related to
study treatment
other" field, the
following text
was indicated in
the comment
field [Car crash].
Any symptoms,
AEs or other key
data should be
collected on the
adverse event
page. Please
review and
update as
necessary.
Oct-20-2020
18:59:25
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related
to study treatm
ent(s), this eve
nt is due to:
OTHER
If Other, sp
ecify:
Car crashInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883501
Page 170 of 178
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-20-2020 18:59:25
(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-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-20-2020 18:59:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883502
Page 171 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-07-2020 11:03:49
(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-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
subgaleal hematomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Sep/20/2020 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-25-2020 11:35:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-25-2020 09:34:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-25-2020 09:34:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria Beretta Data Entry:
NO
End Date Time:
Nov/9/2020 09:30New Information
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883503
Page 172 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-25-2020 06:40:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if AE is
ONGOING or has
RESOLVED. If event
has RESOLVED,
please update AE
record accordingly
and enter END DATE.
Nov-07-2020 11:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-07-2020 11:03:49
(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
Nov-07-2020 11:03:49
(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-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (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-2021-5683-0883504
Page 173 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
OTHER
If Other, specify:
road accident
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-07-2020 11:03:49
(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
Nov-25-2020 10:22:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-25-2020 10:22:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-25-2020 09:34:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE subgaleal
hematoma: Response to
"What was the outcome
of this adverse event?"
is
'Recovering/Resolving'
but AE End Date/Time
is present.
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883505
Page 174 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-07-2020 11:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-07-2020 11:03:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883506
Page 175 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-15-2021 13:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-15-2021 13:07:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0883507
Page 176 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020 11:57:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-09-2020 23:45:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-09-2020 16:22:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered subject has schedule
visit 3 the next 12
nov. She could not do
it before because she
was recovering of AE
(polytrauma).
Nov-09-2020 15:48:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Subject had VAX2 on
16 Sep 2020. Please
confirm if subject
returned for Visit 3. If
yes, please complete
appropriate records
and update EOT
record.
Aug-27-2020 13:28:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-27-2020 13:26:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-12-2020 11:57:56
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
Aug-27-2020 13:28:55
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-27-2020 13:26:07
(UTC-03:00) City of BuenosACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883508
Page 177 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4)
FDA-CBER-2021-5683-0883509
Page 178 of 178
***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314407 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 14:30:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2eeb\Final\Final On: 01-Apr-2021 03:27 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0883510
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