125742 S1 M5 CRF c4591001 1231 12314216

Document text

Page 1 of 159
***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: 12314216 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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881923
Page 2 of 159
***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: 12314216 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/26/2020
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881924
Page 3 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314216]
2.Birth Date: /1963
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0881925
Page 4 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881926
Page 5 of 159
***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: 12314216 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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881927
Page 6 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881928
Page 7 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881929
Page 8 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [91.0]
3.Unit: kg
4.Height: [163.0]
5.Unit: cm
6.Body Mass Index: [34.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881930
Page 9 of 159
***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: 12314216 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/26/2020
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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881931
Page 10 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [241584]
3.Randomization Group: [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881932
Page 11 of 159
***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: 12314216 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/26/2020
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 [BNV24Z]
5.bSample ID [BNV250]
5.cSample ID [BNV251]
5.dSample ID [BPTF8B]
5.eSample ID [BPTF8D]
5 fSample ID [BPTF8C]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881933
Page 12 of 159
***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: 12314216 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/26/2020
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 [BPT9RX]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881934
Page 13 of 159
***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: 12314216 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/26/2020 14:50
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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881935
Page 14 of 159
***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: 12314216 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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881936
Page 15 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit //
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881937
Page 16 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L 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: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881938
Page 17 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881939
Page 18 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L 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: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881940
Page 19 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L 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: 12314216 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?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881941
Page 20 of 159
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881942
Page 21 of 159
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: 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: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881943
Page 22 of 159
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881944
Page 23 of 159
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881945
Page 24 of 159
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881946
Page 25 of 159
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881947
Page 26 of 159
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881948
Page 27 of 159
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881949
Page 28 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881950
Page 29 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 12314216 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: [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881951
Page 30 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881952
Page 31 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881953
Page 32 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 12314216 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?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881954
Page 33 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881955
Page 34 of 159
***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: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881956
Page 35 of 159
***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: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881957
Page 36 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881958
Page 37 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881959
Page 38 of 159
***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: 12314216 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/26/2020
2.Phase of Disposition: VACCINATION
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [due to health problems]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881960
Page 39 of 159
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Nov/26/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [due to health problems]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881961
Page 40 of 159
***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: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881962
Page 41 of 159
***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: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881963
Page 42 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881964
Page 43 of 159
***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: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881965
Page 44 of 159
***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: 12314216 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:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881966
Page 45 of 159
***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: 12314216 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?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881967
Page 46 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881968
Page 47 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881969
Page 48 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881970
Page 49 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881971
Page 50 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881972
Page 51 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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 [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881973
Page 52 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881974
Page 53 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881975
Page 54 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# CategoryAE Iden
tifierAdverse Even
tStart DateIs the Adverse Event S
till OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  Acute Appendi
citis Sep/5/2020 22:
00 NO
End Date Time:
Sep/9/2020 14:00
 Repeating
Pages
 2. ADVERSE
EVENT 2  orthostatic hyp
otension Oct/11/2020 0
6:30 NO
End Date Time:
Oct/12/2020 13:00
 Repeating
Pages
 3. ADVERSE
EVENT 3  Vertigo  Oct/7/2020 U
NK:UNK NO
End Date Time:
Nov/26/2020 21:00
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  orthostatic hyp
otension Oct/11/2020 0
6:30 NO
End Date Time:
Oct/12/2020 13:00
 Repeating
Pages
 5. DELETED ADVERSE
EVENT 5  Vertigo  Oct/7/2020 01:
00 YES  Repeating
Pages
 6. DELETED ADVERSE
EVENT 6  acute abdomen
 Sep/8/2020 13:
20 NO
End Date Time:
Sep/9/2020 14:00
 Repeating
Pages
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881976
Page 55 of 159
***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: 12314216 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)[Acute Appendicitis]
4.Start Date Time: Sep/5/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 14:00
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?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881977
Page 56 of 159
***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: 12314216 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.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:
[unknown]
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[2020346111]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881978
Page 57 of 159
***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: 12314216 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)[orthostatic hypotension]
4.Start Date Time: Oct/11/2020 06:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/12/2020 13:00
6.Toxicity Grade: 1
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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881979
Page 58 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
[dietary habit change, lower intake.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881980
Page 59 of 159
***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: 12314216 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vertigo]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/26/2020 21:00
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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881981
Page 60 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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:
[Unknow]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881982
Page 61 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[orthostatic hypotension ]
4.Start Date Time: Oct/11/2020 06:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/12/2020 13:00
6.Toxicity Grade: 1
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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881983
Page 62 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[dietary habit change, lower intake. ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881984
Page 63 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vertigo]
4.Start Date Time: Oct/7/2020 01:00
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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881985
Page 64 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881986
Page 65 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[acute abdomen ]
4.Start Date Time: Sep/8/2020 13:20
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 14:00
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?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881987
Page 66 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[acute appendicitis ]
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[ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881988
Page 67 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881989
Page 68 of 159
***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: 12314216 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[ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881990
Page 69 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881991
Page 70 of 159
***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: 12314216 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: //
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881992
Page 71 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881993
Page 72 of 159
***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: 12314216 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?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881994
Page 73 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881995
Page 74 of 159
***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: 12314216 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?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881996
Page 75 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881997
Page 76 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881998
Page 77 of 159
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: 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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0881999
Page 78 of 159
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882000
Page 79 of 159
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882001
Page 80 of 159
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Nov/26/2020
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882002
Page 81 of 159
***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: 12314216 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: [ ]
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882003
Page 82 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/26/2020
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882004
Page 83 of 159
***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: 12314216 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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882005
Page 84 of 159
***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: 12314216 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
 Approved Feb-17-2021 20:43:55 (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.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882006
Page 85 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-26-2020 16:09:02 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882007
Page 86 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-26-2020 16:09:33 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882008
Page 87 of 159
***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: 12314216 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
 Approved Feb-17-2021 20:43:55 (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-02-2020 12:11:44 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-27-2020 19:47:04 (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.
 N/A Nov-27-2020 08:15:10 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882009
Page 88 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
N/A
 Approved Nov-06-2020 18:45:25 (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 Oct-31-2020 18:30:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-31-2020 13:20:36 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, FernandoPolack, 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.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882010
Page 89 of 159
***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: 12314216 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-26-2020 16:08:06
(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-26-2020 16:08:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882011
Page 90 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 16:08:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/26/2020Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882012
Page 91 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 13:22:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314216Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 13:22:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1963Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 16:08:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 16:08:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 16:08:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882013
Page 92 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 11:01:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Recommend
confirming with
participant if they
wish to continue
in the study or
withdrawal.
Nov-01-2020 21:29:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The patient reports
a sensation of
movement or
twisting that she
describes as
dizziness and
causes instability
in her gait.
Therefore, he still
did not attend the
pending protocol
visit (V2). The
patient at this time
(28OCT) is
reluctant to attend.
Oct-30-2020 13:19:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if there is
a TEMP DELAY
for VAX 2 and if
subject is
continuing in the
study. Please
update applicable
records as needed.
Aug-26-2020 16:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882014
Page 93 of 159
***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: 12314216 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-26-2020 16:09:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 16:09:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 16:09:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882015
Page 94 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
91.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
163.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
cmInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882016
Page 95 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34.3Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.2
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882017
Page 96 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 16:10:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882018
Page 97 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882019
Page 98 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
6.a
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-26-2020 16:10:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882020
Page 99 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 16:10:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 16:10:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
241584Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882021
Page 100 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 16:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 16:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 08:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 02:18:20
(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-26-2020 16:10:48
(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-26-2020 16:10:48 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882022
Page 101 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresYES
Date of Collection:
Aug/26/2020
5.a
Date Location User Value Reason
Aug-27-2020 08:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV24ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 08:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV24ZInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 08:39:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV250Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 08:39:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV250Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 08:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV251Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882023
Page 102 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 08:39:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV251Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020 17:12:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTF8BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 17:12:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTF8BInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020 17:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTF8DInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 17:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTF8DInitial Entry
5.f
Date Location User Value Reason
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882024
Page 103 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-27-2020 17:12:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPTF8CInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-27-2020 17:12:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPTF8CInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882025
Page 104 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 16:10:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 16:10:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 14:58:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 02:18:20
(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-26-2020 16:10:55
(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-26-2020 16:10:55 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882026
Page 105 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresYES
Date of Collection:
Aug/26/2020
5.a
Date Location User Value Reason
Aug-27-2020 14:58:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BPT9RXInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 14:58:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BPT9RXInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882027
Page 106 of 159
***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: 12314216 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-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/26/2020 14:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882028
Page 107 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
6. Body Side:
Date Location User Value Reason
Aug-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020 16:11:18
(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-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-26-2020 16:11:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882029
Page 108 of 159
***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: 12314216 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
Sep-02-2020 12:09:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTChanged
Information
Aug-26-2020 16:11:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E
-DIARY COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882030
Page 109 of 159
***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: Incomplete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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-30-2020 04:04:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-28-2020 16:14:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered So far we do not
have more
information to
update on this
subject. We are
waiting for you to
attend visit 2.
Thank you.
Sep-29-2020 08:48:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thank you
for the response.
Please keep this
query open at your
end. Once visit is
performed, kindly
update vaccination
details and rest of
the visit pages and
then respond to
the query.
Sep-28-2020 11:18:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered V2 opened due to
loading error. No
information to
load.
Sep-26-2020 12:19:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: Kindly
review and
complete ‘Date of
Visit, Nasal Swab,
Pregnancy Test,
Vaccination, Vital
Signs' forms at
this visit. Thank
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882031
Page 110 of 159
***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: Incomplete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
you.
2. Erroneous Visit
Date Location User Value Reason
Sep-28-2020 11:18:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882032
Page 111 of 159
***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: 12314216 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-27-2020 08:15:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-27-2020 08:15:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-27-2020 08:15:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-27-2020 08:15:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
due to health problemsInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882033
Page 112 of 159
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-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: 12314216 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-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
due to health problemsInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882034
Page 113 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882035
Page 114 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882036
Page 115 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882037
Page 116 of 159
***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: 12314216 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
Nov-02-2020 08:35:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted this adverse
event was
duplicated.
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882038
Page 117 of 159
***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: 12314216 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
Nov-02-2020 18:07:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882039
Page 118 of 159
***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: 12314216 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
Dec-02-2020 12:11:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted This advers
event will be
deleted due
correspond to
advers event 1
"acute
apendicitis"
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882040
Page 119 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-16-2020 11:13:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Closed Response satisfies
query
Oct-13-2020 12:40:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered symptoms are
interpreted as not
related to potential
covid illness.
diagnosis was
surgical acute
abdomen, secondary
to appendicitis.
therefore no covid
visit nor swab
sample is triggered.
Oct-05-2020 00:58:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: Please
potential COVID
Illness Visit CRF
forms should be
completed with all
information
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882041
Page 120 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
available. NASAL
SWAB will not be
collected. Protocol
deviation will be
documented.
Oct-04-2020 15:33:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered There was no visit
due to covid as he
was diagnosed with
acute appendicitis. It
was also not
considered
necessary to
perform a swab.
Sep-30-2020 02:52:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: Please
COVID-19 protocol
listed symptom
DIARRHEA and
VOMITING should
trigger a COVID
Illness Visit. The
diagnostic of Acute
Appendicitis should
be entered on the
Illness details CRF
form. A Nasal Swab
will not be
collected.
Sep-28-2020 10:20:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered By decision of the
investigator, the
symptoms within
the acute abdomen
are interpreted, and
not separately, since
the resolution is
joint with the
surgery performed.
Sep-24-2020 09:20:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 3: Opened Clin: Please
COVID-19 protocol
listed symptom
DIARRHEA and
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882042
Page 121 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
VOMITING should
trigger a COVID
Illness Visit
irrespective of the
diagnostic of Acute
Appendicitis. A
Nasal Swab will not
be collected.
Sep-17-2020 23:46:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-17-2020 15:44:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Sep-17-2020 15:44:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Acute AppendicitisNew Information
Sep-16-2020 09:15:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened SAE RECON:
AER#2020346111
The term in Safety
database was
updated to 'Acute
Appendicitis'
however retained as
Acute abdomen in
AE CRF. Please
confirm. If safety
update is required,
please submit a
follow-up form.
Sep-14-2020 16:56:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satifies
SAE queries
received from DSU.
Sep-14-2020 16:30:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered According to the
source document,
the start of the SAE
was on Sep 5, 2020
at 10 p.m. Thank
you.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882043
Page 122 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-11-2020 15:26:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened According to
medical records,
subject was
admitted to the
emergency room on
06-Sep-2020 and no
specific time of
admission is
present. Please
kindly review and
amend if
appropriate. Thank
you.
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Acute abdomenInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020 16:26:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/5/2020 22:00New Information
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/7/2020 00:54Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-16-2020 13:48:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-15-2020 15:41:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINQuery:
Please submit a
follow-up SAE
Report to indicate
the status of the
event including
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882044
Page 123 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
END DATE and
Time.
Additionally,
please provide
follow-up
information (ex -
lab results) and
clinical outcome
of the acute
abdomen in
follow-up report
submitted
Sep-15-2020 11:40:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-14-2020 16:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Sep-14-2020 16:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/9/2020 14:00New Information
Sep-14-2020 13:58:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery:
According to the
SAE Report, the
subject was
evaluated by a
surgeon. Please
confirm if acute
abdomen required
a surgical
procedure.
Confirm if subject
was hospitalized >
24 hrs. Please
confirm if AE
resolved. If event
resolved, enter
END DATE.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882045
Page 124 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-02-2020
10:01:33 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-31-2020 19:07:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: 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. Serious
adverse event
follow-up form sent
on 10/29/2020.
Thank you
Oct-30-2020 22:42:01 ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical – Thank
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882046
Page 125 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos Airesyou. 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 12:09:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: 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 15:30:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE
form
[#2020346111] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Sep-16-2020 09:12:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed SDB subject
number updated.
issue resolved
Sep-16-2020 08:21:02
(UTC-03:00) City ofACV0PFEINFP6000  Query 1: Answered The correct subject
number as
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882047
Page 126 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires 12314216 has
already been
cleared. Thank you.
Sep-14-2020 06:34:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened SAE RECON:The
subject number for
AER 2020346111
was reported as
12314126.Please
submit a follow up
AEM form to
indicate the correct
subject number as
12314216.
Sep-09-2020 13:25:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed CLINRESPOSE:
Sent in error.
Sep-09-2020 13:19:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened CLINQUERY:
Please see protocol
section 8.3.1.1
Reporting Serious
AEs to Pfizer
Safety. SAEs are
reported to Pfizer
Safety on the
Vaccines SAE
Report Form
immediately upon
awareness and
under no
circumstance
should this exceed
24 hours.
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Acute
abdomen: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882048
Page 127 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event assoc
iated with congenital ano
maly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
YES
Did this serious event res
ult in persistent or signific
ant disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically importan
t serious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882049
Page 128 of 159
***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: 12314216 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
Sep-15-2020 13:00:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
unknownTranscription Error
Sep-09-2020 13:21:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Acute appendicitisNew Information
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882050
Page 129 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020 09:22:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew Information
Sep-08-2020 11:43:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-08-2020 11:43:59
(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
Sep-14-2020 16:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-14-2020 16:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Sep-14-2020 16:27:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Acute
abdomen: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882051
Page 130 of 159
***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: 12314216 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
Sep-08-2020 11:43:59
(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
Sep-08-2020 11:43:59
(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
Sep-16-2020 09:12:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2020346111Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882052
Page 131 of 159
***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: 12314216 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 08:45:21
(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 08:45:21
(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-26-2020
16:28:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
ClosedResponse satisfies
query
Oct-23-2020
11:02:51
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Julieta Gelardi Query 2:
Answere
dThe subject has
no medical
history of
orthostatic
hypotension.
Thank you
Oct-19-2020
12:29:49
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2:
OpenedClinQuery: Please
confirm if subject
has past medical
history of
'orthostatic
hypotension'. If
yes, please update
the Medical
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882053
Page 132 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
History record.
Oct-19-2020
12:15:19
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1:
ClosedDiscrepancy has
been closed.
Oct-19-2020
10:33:51
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1:
Answere
dChanged
Information
Oct-19-2020
10:33:51
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
orthostat
ic hypot
ensionChanged
Information
Oct-16-2020
11:36:41
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1:
OpenedMultiple concepts
in the term
ORTHOSTATIC
HYPOTENSION,
NAUSEA.. Split
the term into
ORTHOSTATIC
HYPOTENSION
and NAUSEA
and submit
separately. Thank
you.
Oct-16-2020
08:45:21
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data En
try:
orthostat
ic hypot
ension,
nausea.Initial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882054
Page 133 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/11/2020 06:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/12/2020 13:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial 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 08:45:21
(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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882055
Page 134 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-16-2020 08:45:21
(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-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
dietary habit change, lowe
r intake.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-16-2020 08:45:21
(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 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-16-2020 08:45:21 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0882056
Page 135 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresNO
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-16-2020 08:45:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882057
Page 136 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-03-2020 11:01:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 18:10:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Duplicate data,
the second loaded
is deleted.
Nov-02-2020 14:33:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: AE
Record includes 2
AEs of Vertigo
with same
ONSET date.
Please confirm if
duplication is
recorded. Please
update AE Record
as needed.
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VertigoInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882058
Page 137 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-27-2020 13:15:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-27-2020 13:15:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/26/2020 21:00New Information
Nov-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing.
Please review and
update as
appropriate.
Nov-02-2020 11:01:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Site response to
another query
confirms that AE
is still ONGOING.
Oct-31-2020 11:49:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESTranscription
Error
Oct-30-2020 19:06:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-30-2020 19:06:31 ACV0PFEINFP6000  Tatiana Estrada Data Entry: Changed
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0882059
Page 138 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresNO
End Date Time:
Oct/12/2020 13:00Information
Oct-30-2020 13:15:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if AE is
ONGOING (start
date 7 OCT 2020)
or has
RESOLVED. If
RESOLVED,
please update AE
Record and enter
END date.
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 08:24:50
(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-29-2020 08:24:50
(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.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882060
Page 139 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UnknowInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User ValueReason
Oct-31-2020
03:37:58
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: Clo
sedResponse
satisfies query
Oct-30-2020
09:56:16
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Oct-30-2020
09:56:16
(UTC-03:00)
City of
BuenosACV0PFEINFP6000  Data
Entry
:
NOT
APPLTranscription
Error
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882061
Page 140 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aires ICAB
LE
Oct-30-2020
04:47:15
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedThe Adverse
Event Action
Taken is
DRUG
WITHDRAWN
but reason for
treatment
discontinuation
is not reported
as ADVERSE
EVENT or
DEATH. Please
review and
clarify.
Oct-29-2020
08:24:50
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
DRU
G WI
THD
RAW
NInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882062
Page 141 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-27-2020
13:16:02 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-27-2020
13:16:02 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DNew Information
Nov-27-2020
13:15:53 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Vertigo:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Nov-03-2020
03:38:23 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Query 1: Closed AE updated as
Ongoing; hence
query closed.
Oct-31-2020 11:45:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The adverse event
continues as it
refers to a
sensation of
movement or turns
that it describes as
dizziness and
causes instability
in walking. At the
moment he is
reluctant to attend.
Thank you
Oct-30-2020 19:06:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Vertigo:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882063
Page 142 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Resolved' but AE
End Date/Time is
present.
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 08:24:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882064
Page 143 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-31-2020 18:30:05
(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-04-2020 03:47:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed data deleted.
Nov-02-2020 08:34:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered This adverse event
was duplicated. It
will be deleted.
Nov-02-2020 06:12:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The Adverse
Event orthostatic
hypotension on
record 4 has
overlapping dates
with a record with
the same AE Term
and Toxicity
Grade on record 2.
Please verify and
correct as
appropriate.
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882065
Page 144 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
orthostatic hypotensionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/11/2020 06:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/12/2020 13:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial 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
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882066
Page 145 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-31-2020 18:30:05
(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-31-2020 18:30:05
(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-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
dietary habit change, low
er intake.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882067
Page 146 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-31-2020 18:30:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882068
Page 147 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VertigoInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/7/2020 01:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882069
Page 148 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Buenos Aires
6. Toxicity Grade:
Date Location User Value Reason
Oct-31-2020 18:55:44
(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-31-2020 18:55:44
(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-31-2020 18:55:44
(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-31-2020 18:55:44
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882070
Page 149 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Buenos Aires If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (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-2021-5683-0882071
Page 150 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-31-2020 18:55:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882072
Page 151 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 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
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
acute abdomenInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/8/2020 13:20Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882073
Page 152 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Sep/9/2020 14:00
6. Toxicity Grade:
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-04-2020
02:49:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed form inactivated
Dec-02-2020
12:10:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered This advers event
will be deleted due
correspond to advers
event 1 "acute
apendicitis"
Dec-01-2020
09:41:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened SAE RECON:
ACUTE
ABDOMEN(Onset
date:05Sep2020) is
not reported to
Safety database but
updated to serious
on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0882074
Page 153 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
downgrade the event
on AE CRF
Dec-01-2020
09:39:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Nov-27-2020
17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE acute
abdomen: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-27-2020
17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital a
nomaly or birth defect?
NO
Did this serious event re
sult in death?
NO
Did this serious event re
quire or prolong hospital
ization?
YES
Did this serious event re
sult in persistent or signi
ficant disability/incapaci
ty?
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882075
Page 154 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Is this serious event life
threatening?
NO
Other medically importa
nt 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.
Date Location User Value Reason
Nov-27-2020 17:52:45
(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-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
acute appendicitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882076
Page 155 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr.
Cosme Argerich
Subject No: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-27-2020 17:52:45
(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-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-27-2020 17:52:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882077
Page 156 of 159
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - 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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Nov-27-2020 08:15:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/26/2020Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882078
Page 157 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-27-2020 08:15:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-09-2020 23:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-09-2020 17:21:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The volunteer will
attend visit 2.
Pending date.
Nov-09-2020 16:51:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery:
Subject had
VAX1 on 24 Aug
2020. Please
confirm if subject
will return for
VAX2. If YES,
please complete
appropriate
records.
Aug-26-2020 16:10:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Aug-26-2020 16:09:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0882079
Page 158 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Nov-27-2020 08:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/26/2020Initial Entry
Nov-27-2020 08:15:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/26/2020Initial Entry
Aug-26-2020 16:10:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
Aug-26-2020 16:09:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/26/2020Initial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
FDA-CBER-2021-5683-0882080
Page 159 of 159
***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: 12314216 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-31-2020 13:20:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Fernando
PolackData Entry:
Click Here to EnableInitial Entry
090177e196ae2e45\Final\Final On: 01-Apr-2021 03:09 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0882081