125742 S1 M5 CRF c4591001 1231 12314035

Document text

Page 1 of 160
***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: 12314035 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
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880231
Page 2 of 160
***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: 12314035 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/25/2020
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880232
Page 3 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314035]
2.Birth Date: /1957
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): NOT REPORTED
6.Racial Designation:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880233
Page 4 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880234
Page 5 of 160
***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: 12314035 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
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880235
Page 6 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880236
Page 7 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acute myocardial infarction]
Start Date: Sep/21/2018
Ongoing: NO
End Date:
Sep/23/2018
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipemia]
Start Date: Sep/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroduodenal Bleeding Ulcer]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diverticulitis]
Start Date: Apr/1/2018
Ongoing: NO
End Date:
Apr/15/2018
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880237
Page 8 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colon Resection]
Start Date: Apr/15/2018
Ongoing: NO
End Date:
Apr/15/2018
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arterial Hypertension]
Start Date: Sep/23/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heavy Smoking]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/2007
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[angioplasty with stent placement]
Start Date: Sep/21/2018
Ongoing: NO
End Date:
Sep/21/2018
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880238
Page 9 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [79.15]
3.Unit: kg
4.Height: [166.0]
5.Unit: cm
6.Body Mass Index: [28.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880239
Page 10 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [240684]
3.Randomization Group: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880240
Page 11 of 160
***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: 12314035 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/25/2020
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 [BPT933]
5.bSample ID [BPT934]
5.cSample ID [BPT935]
5.dSample ID [BNVBLH]
5.eSample ID [BNVBLJ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880241
Page 12 of 160
***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: 12314035 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/25/2020
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 [BP2F9G]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880242
Page 13 of 160
***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: 12314035 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/25/2020 18:45
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
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880243
Page 14 of 160
***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: 12314035 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
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880244
Page 15 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880245
Page 16 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880246
Page 17 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP2FNF]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880247
Page 18 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/14/2020 16:25
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
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880248
Page 19 of 160
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880249
Page 20 of 160
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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:
Oct/15/2020
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 [BRVGZ6]
5.bSample ID [BPW60C]
5.cSample ID [BRVGYB]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880250
Page 21 of 160
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/22/2021
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880251
Page 22 of 160
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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:
Mar/22/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS1VW4]
5.bSample ID [BR1YY1]
5.cSample ID [BS1VV1]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880252
Page 23 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880253
Page 24 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880254
Page 25 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880255
Page 26 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880256
Page 27 of 160
***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: 12314035 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:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880257
Page 28 of 160
***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: 12314035 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: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880258
Page 29 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880259
Page 30 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880260
Page 31 of 160
***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: 12314035 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?
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880261
Page 32 of 160
***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: 12314035 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:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880262
Page 33 of 160
***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: 12314035 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:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880263
Page 34 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880264
Page 35 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880265
Page 36 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880266
Page 37 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880267
Page 38 of 160
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880268
Page 39 of 160
***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: 12314035 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:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880269
Page 40 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880270
Page 41 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880271
Page 42 of 160
***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: 12314035 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:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880272
Page 43 of 160
***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: 12314035 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?
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880273
Page 44 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880274
Page 45 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880275
Page 46 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880276
Page 47 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880277
Page 48 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880278
Page 49 of 160
***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: 12314035 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 [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880279
Page 50 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880280
Page 51 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880281
Page 52 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# CategoryAE Identi
fierAdverse Ev
entStart DateIs the Adverse Event Still
OngoingForm Instanc
e
 1. ADVERSE EV
ENT 1  Angina Pect
oris Sep/20/2020 1
7:00 NO
End Date Time:
Sep/24/2020 08:30
 Repeating
Pages
 2. ADVERSE EV
ENT 2  Anxiety Cry
sis Sep/29/2020 1
2:00 NO
End Date Time:
Sep/29/2020 18:30
 Repeating
Pages
 3. DELETED ADVERSE EV
ENT 3  anxiety crisi
s Sep/29/2020 1
2:00 NO
End Date Time:
Sep/29/2020 18:30
 Repeating
Pages
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880282
Page 53 of 160
***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: 12314035 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)[Angina Pectoris]
4.Start Date Time: Sep/20/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/24/2020 08:30
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880283
Page 54 of 160
***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: 12314035 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:
[coronary disease]
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[2020380582]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880284
Page 55 of 160
***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: 12314035 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)[Anxiety Crysis]
4.Start Date Time: Sep/29/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/29/2020 18:30
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Angina Pectoris]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880285
Page 56 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?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[ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880286
Page 57 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[anxiety crisis ]
4.Start Date Time: Sep/29/2020 12:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/29/2020 18:30
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880287
Page 58 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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:
[Angina pectoris ]
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[ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880288
Page 59 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880289
Page 60 of 160
***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: 12314035 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[ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880290
Page 61 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880291
Page 62 of 160
***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: 12314035 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: //
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880292
Page 63 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880293
Page 64 of 160
***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: 12314035 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?
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880294
Page 65 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880295
Page 66 of 160
***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: 12314035 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?
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880296
Page 67 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880297
Page 68 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880298
Page 69 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880299
Page 70 of 160
***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: 12314035 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?
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880300
Page 71 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880301
Page 72 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880302
Page 73 of 160
***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: 12314035 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: [ ]
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880303
Page 74 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880304
Page 75 of 160
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880305
Page 76 of 160
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880306
Page 77 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-25-2020 21:13:52 (UTC-03:00) City of
Buenos AiresMartina Davalli Not Applicable
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880307
Page 78 of 160
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-22-2021 11:41:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-04-2021 18:27:12 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-03-2021 16:17:09 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-26-2020 10:54:51 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880308
Page 79 of 160
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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.
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880309
Page 80 of 160
***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: 12314035 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-25-2020 21:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020 21:13:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880310
Page 81 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 21:13:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880311
Page 82 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020 17:31:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314035Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 17:31:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1957Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 21:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 21:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 11:21:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-09-2020 09:15:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value is
correct
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880312
Page 83 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-09-2020 02:45:43
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Clin Query:
Ethnicity
completed, yet
Race not reported.
Please add Race or
confirm subject
refused.
Sep-08-2020 15:56:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Candidate Clin Query:
Ethnicity
completed, yet
Race not reported.
Please add Race or
confirm subject
refused.
Aug-25-2020 21:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina Davalli Data Entry:
NOT REPORTEDInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880313
Page 84 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 21:13:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Aug/25/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880314
Page 85 of 160
***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: 12314035 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-25-2020 21:14:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 21:14:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 21:14:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
COMPLETEDInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880315
Page 86 of 160
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 21:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Acute myocardial
infarction
Start Date: Sep/21/2018
Ongoing: NO
End Date:
Sep/23/2018Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 21:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020 14:35:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-22-2020 19:06:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered I clarify that the
NSTEMI medical
history is already
separated from the
angioplasty (and
stent placement)
medical history
Oct-18-2020 23:44:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened CLINICAL SAE
reports a separate
past medical history
of NSTEMI with
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880316
Page 87 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
angioplasty (and
stent placement);
please add this
separate cardiac
event to medical
history
Oct-14-2020 11:31:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-12-2020 15:26:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened According to query
response, the
subject has medical
history of HTN,
smoker, Upper GI
bleed, colon
resection, and
NSTEMI. Please
update Medical
History record to
include this Disease
Syndromes. Please
review CRF
completion
instructions Section
8.7.
Oct-12-2020 12:03:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Follow-up query
entered for
clarification.
Oct-12-2020 12:03:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Candidate According to query
response, the
subject has medical
history of HTN,
smoker, Upper GI
bleed, colon
resection, and
NSTEMI. Please
update Medical
History record to
include this Disease
Syndromes. Please
review CRF
completion
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880317
Page 88 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
instructions Section
8.7.
Oct-09-2020 15:47:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery:SAE
indicates medical
history included
hypertension,
former smoker,
upper GI bleeding
(gastroduodenal
ulcer)1998, colonic
resection due to
diverticulitis
Apr2018,
(NSTEMI)(with
percutaneous
transluminal
angioplasty).
Oct-09-2020 15:43:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Candidate ClinQuery:SAE
indicates medical
history included
hypertension,
former smoker,
upper GI bleeding
(gastroduodenal
ulcer)1998, colonic
resection due to
diverticulitis
Apr2018,
(NSTEMI)(with
percutaneous
transluminal
angioplasty).
Aug-25-2020 21:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina Davalli Data Entry:
Acute myocardial infarctionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 21:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/21/2018Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880318
Page 89 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 21:15:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO
End Date:
Sep/23/2018Initial Entry
1.b
Date Location User Value Reason
Oct-13-2020 10:51:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Dyslipemia
Start Date: Sep/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880319
Page 90 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b Line/MH Number:
Date Location User Value Reason
Oct-13-2020 10:51:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 10:51:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DyslipemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-13-2020 10:51:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-13-2020 10:51:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-23-2020 10:51:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Gastroduodenal
Bleeding Ulcer
Start Date: UNK/UNK/1998Transcription Error
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880320
Page 91 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Ongoing: NO
End Date:
UNK/UNK/1
998
Oct-22-2020 18:50:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Gastroduodenal
Bleeding Ulcer
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1
998Transcription Error
Oct-14-2020 10:20:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:Gastroduoden
al ulcer
Start Date: UNK/UNK/19
98
Ongoing: NO
End Date:
UNK/UNK
/1998New Information
Oct-13-2020 10:53:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Gastroduoden
al ulcer
Start Date: UNK/UNK/1
998
Ongoing: NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880321
Page 92 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Line/MH Number:
Date Location User Value Reason
Oct-13-2020 10:53:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020
12:27:55
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Clo
sedDiscrepancy has
been closed.
Oct-23-2020
10:51:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: An
sweredTranscription
Error
Oct-23-2020
10:51:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Gastroduode
nal Bleeding
UlcerTranscription
Error
Oct-23-2020
10:50:16
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Clo
sedResponse
satisfies query
Oct-23-2020
02:19:20
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Op
enedSpacing:
Verbatim Term
contains leading,
trailing or more
than one
consecutive
space.
Oct-22-2020
18:50:42
(UTC-03:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredTranscription
Error
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880322
Page 93 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
City of Buenos
Aires
Oct-22-2020
18:50:42
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Gastroduode
nal Bleeding
UlcerTranscription
Error
Oct-14-2020
15:47:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Op
enedAccording to the
SAE report, the
subject has past
medical history
for GI Bleed. If
the
Gastroduodenal
Ulcer is site of
GI Bleed,
consider to
update the term
to include
Gastroduodenal
Bleeding Ulcer.
If GI bleed is
from another
site, please
update record.
Oct-13-2020
10:53:12
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Gastroduode
nal ulcerInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-13-2020 10:53:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880323
Page 94 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-15-2020 04:30:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-14-2020 10:20:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-14-2020 10:20:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1998New Information
Oct-14-2020 09:18:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The response
for "Ongoing
reported as 'No'
however End date
is missing? Kindly
review and update.
Oct-13-2020 10:53:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-14-2020 10:22:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Diverticuliti
s
Start Date: Apr/1/2018
Ongoing: NO
End Date:
Apr/15/2
018New Information
Oct-13-2020 10:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Diverticuli
tisInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880324
Page 95 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Start Date: Apr/15/20
18
Ongoing: NO
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880325
Page 96 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.d Line/MH Number:
Date Location User Value Reason
Oct-13-2020 10:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 10:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DiverticulitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-14-2020 10:22:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Apr/1/2018New Information
Oct-13-2020 10:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Apr/15/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-15-2020 04:28:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-14-2020 10:22:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-14-2020 10:22:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/15/2018New Information
Oct-14-2020 09:18:37
(UTC-03:00) City ofACV0PFEINFP6000  Query 1: Opened DM: The response
for "Ongoing
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880326
Page 97 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires reported as 'No'
however End date
is missing? Kindly
review and update.
Oct-13-2020 10:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880327
Page 98 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.e
Date Location User Value Reason
Oct-14-2020 10:22:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Colon Resec
tion
Start Date: Apr/15/2018
Ongoing: NO
End Date:
Apr/15/2
018New Information
Oct-13-2020 10:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Colon Resec
tion
Start Date: Apr/15/2018
Ongoing: NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880328
Page 99 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.e Line/MH Number:
Date Location User Value Reason
Oct-13-2020 10:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 10:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Colon ResectionInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-13-2020 10:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Apr/15/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-15-2020 04:28:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-14-2020 10:22:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-14-2020 10:22:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/15/2018New Information
Oct-14-2020 09:18:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The response
for "Ongoing
reported as 'No'
however End date
is missing? Kindly
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880329
Page 100 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
review and update.
Oct-13-2020 10:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-14-2020 13:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Arterial Hyper
tension
Start Date: Sep/23/2018
Ongoing: YESNew Information
Oct-13-2020 10:56:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Arterial Hyper
tension
Start Date:
Ongoing:Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880330
Page 101 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.f Line/MH Number:
Date Location User Value Reason
Oct-13-2020 10:56:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 10:56:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Arterial HypertensionInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-15-2020 04:29:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-14-2020 13:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-14-2020 13:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/23/2018New Information
Oct-14-2020 09:20:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The response
for "Start Date and
ongoing" are
missing. Kindly
review and update.
1.f Ongoing:
Date Location User Value Reason
Oct-14-2020 13:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew Information
1.g
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880331
Page 102 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-14-2020 13:24:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Heavy Smokin
g
Start Date: UNK/UNK/19
75
Ongoing: NO
End Date:
UNK/UNK
/2007New Information
Oct-13-2020 11:26:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Heavy Smok
ing
Start Date: UNK/UNK/
1975
Ongoing: NOInitial Entry
Oct-13-2020 10:56:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Heavy Smo
king
Start Date:
Ongoing: NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880332
Page 103 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.g Line/MH Number:
Date Location User Value Reason
Oct-13-2020 10:56:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 10:56:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Heavy SmokingInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-13-2020 11:26:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1975Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-15-2020 04:30:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-14-2020 13:24:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-14-2020 13:24:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007New Information
Oct-14-2020 09:19:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened DM: The response
for "Ongoing
reported as 'No'
however End date
is missing? Kindly
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880333
Page 104 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
review and update.
Oct-13-2020 10:56:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.h
Date Location User Value Reason
Oct-23-2020 13:06:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH N
umber:8
Medical His
tory Term:angioplasty with s
tent placement
Start Date: Sep/21/2018
Ongoing: NO
End Date:
Sep/21/2018New Information
Oct-23-2020 13:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH N
umber:8
Medical His
tory Term:angioplasty with s
tent placement
Start Date: Sep/21/2018
Ongoing: NO
End Date:
Sep/UNK/2018New Information
Oct-21-2020 13:54:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:angioplasty with s
tent placement
Start Date: Sep/UNK/2018
Ongoing: NO
End Date:
Sep/UNK/2018Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880334
Page 105 of 160
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.h Line/MH Number:
Date Location User Value Reason
Oct-21-2020 13:54:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020 13:54:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
angioplasty with stent placementInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-23-2020 13:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/21/2018New Information
Oct-21-2020 13:54:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-23-2020 13:06:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Sep/21/2018New Information
Oct-21-2020 13:54:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Sep/UNK/2018Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880335
Page 106 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
79.15Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
166.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880336
Page 107 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.7Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Identifier
::1
Temperature: 36.7
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880337
Page 108 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 21:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880338
Page 109 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 21:16:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 21:16:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
240684Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880339
Page 110 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 21:16:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 21:16:15
(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 13:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 02:55:31
(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-25-2020 21:16:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-25-2020 21:16:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880340
Page 111 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Aug-27-2020 13:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT933Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 13:42:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT933Initial Entry
5.b
Date Location User Value Reason
Aug-27-2020 13:42:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT934Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 13:42:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT934Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 13:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPT935Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880341
Page 112 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 13:42:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPT935Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020 19:09:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNVBLHInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 19:09:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNVBLHInitial Entry
5.e
Date Location User Value Reason
Aug-27-2020 19:09:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNVBLJInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 19:09:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNVBLJInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880342
Page 113 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 21:16:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 21:16:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 08:48:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 02:55:31
(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-25-2020 21:16:22
(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-25-2020 21:16:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880343
Page 114 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Aug-26-2020 08:48:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BP2F9GInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 08:48:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BP2F9GInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880344
Page 115 of 160
***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: 12314035 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-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Aug/25/2020 18:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880345
Page 116 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-25-2020 21:16:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880346
Page 117 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020 21:16:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880347
Page 118 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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-15-2020 08:59:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-13-2020 11:24:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The patient
presented dyspnea,
which was
considered an
adverse event since
he had presented as
an Acute
Myocardial
Infarction and he
consulted for that
reason.
Oct-06-2020 14:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
29SEP2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Sep-17-2020 18:50:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/14/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880348
Page 119 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 18:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 18:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Record Identifier
::1
Temperature: 36.8
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 18:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 18:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 18:50:49
(UTC-03:00) City ofACV0PFEINFP6000  Martina
DavalliData Entry:
CInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880349
Page 120 of 160
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 18:50:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
ORAL CAVITYInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880350
Page 121 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 17:42:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 17:42:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 17:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 17:42:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 17:42:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 17:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP2FNFInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880351
Page 122 of 160
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 17:42:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP2FNFInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880352
Page 123 of 160
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
Sep/14/2020 16:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880353
Page 124 of 160
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-17-2020 18:51:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Martina
DavalliData Entry:
YESInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880354
Page 125 of 160
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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-15-2020 13:46:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880355
Page 126 of 160
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 13:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 13:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 16:29:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 13:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 13:46:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 16:29:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVGZ6Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880356
Page 127 of 160
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 16:29:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVGZ6Initial Entry
5.b
Date Location User Value Reason
Oct-15-2020 17:49:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPW60CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 17:49:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPW60CInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 18:36:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRVGYBInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 18:36:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRVGYBInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880357
Page 128 of 160
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-22-2021 11:41:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/22/2021Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880358
Page 129 of 160
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-22-2021 11:42:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-22-2021 11:42:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-22-2021 17:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-22-2021 11:42:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-22-2021 11:42:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/22/2021Initial Entry
5.a
Date Location User Value Reason
Mar-22-2021 17:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1VW4Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880359
Page 130 of 160
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Mar-22-2021 17:54:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1VW4Initial Entry
5.b
Date Location User Value Reason
Mar-22-2021 17:54:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR1YY1Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-22-2021 17:54:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR1YY1Initial Entry
5.c
Date Location User Value Reason
Mar-23-2021 10:36:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1VV1Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021 10:36:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1VV1Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880360
Page 131 of 160
***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: 12314035 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
Oct-16-2020 15:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 15:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 15:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880361
Page 132 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 16:17:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880362
Page 133 of 160
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-03-2021 16:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 16:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-03-2021 16:17:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880363
Page 134 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880364
Page 135 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880365
Page 136 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-23-2020 20:17:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880366
Page 137 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Oct-13-2020
17:44:00
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Samuel
DychterQuery
1: Clo
sedResponse satisfies query
Oct-13-2020
11:18:25
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Oct-13-2020
11:18:25
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Angin
a Pect
orisTranscription Error
Oct-12-2020
15:08:36
(UTC-03:00)
City ofACV0PFEINFP6000  Samuel
DychterQuery
1: Rei
ssued:
OpeneGPD Clin: Please add the
event terms below to the
subject's medical history.
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880367
Page 138 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos
Airesd
Oct-12-2020
06:22:40
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: Clo
sedPT match in both database.
Acceptable discrepancy
Oct-09-2020
19:09:11
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
3: Clo
sedDiscrepancy has been
closed.
Oct-09-2020
16:41:23
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
3: An
swere
dTranscription Error
Oct-09-2020
16:41:23
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Angin
aTranscription Error
Oct-09-2020
09:44:46
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
3: Op
enedClarify ANGOR as follow...
Are you reporting ANGINA
PECTORIS, ANGOR
MORTIS, ANGOR ANIMI
or others? If so, edit.
Otherwise, clarify. Thank
you.
Oct-09-2020
08:43:26
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dNew Information
Oct-09-2020 ACV0PFEINFP6000  DataNew Information
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0880368
Page 139 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
08:43:26
(UTC-03:00)
City of
Buenos
AiresEntry
:
Angor
Oct-09-2020
08:37:16
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
1: An
swere
dThe patient has a history of:
hypertension, ex-smoker,
UGIB due to
gastroduodenal ulcer in
1998, diverticulitis in April
2018 with colon resection
(location and type of
resection unknown),
STEMI with CTA stent
placement. Thank you
Oct-08-2020
07:59:15
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Query
2: Op
enedSAE
RECON:AER#2020380582,
the term in SDB was
updated to ANGOR' while
retained as 'acute
myocardial infarction' in
AE CRF. Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Oct-02-2020
14:04:01
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Samuel
DychterQuery
1: Op
enedGPD Clin: While the
subject had a history of a
prior MI, please confirm if
there are no other pertinent
items to be added to
medical history, such as
HTN, hyperlipidemia,
tobacco abuse, etc.
Oct-01-2020
13:48:42
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
acute
myoc
ardial
infarct
ionInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880369
Page 140 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020 13:49:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-01-2020 13:49:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/20/2020 17:00Transcription Error
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For acute
myocardial
infarction Start Date
20/Oct/2020, is a
future date relative
to when it was
entered on 01/Oct
/2020. Please
correct.
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-01-2020 13:49:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-01-2020 13:49:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 08:30Transcription Error
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For acute
myocardial
infarction End Date
24/Oct/2020, is a
future date relative
to when it was
entered on 01/Oct
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880370
Page 141 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
/2020. Please
correct.
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/24/2020 08:30Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-01-2020 13:48:42
(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
Oct-28-2020 01:40:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-27-2020 19:35:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered It is clarified that
shortness of breath
is reported in the
initial EA as
dyspnea. Thank you
Oct-26-2020 13:55:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Reissued:Opened CLINICAL - please
clarify 'dyne' and
enter an AE for SOB
if this event
occurred.
Oct-26-2020 13:54:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Closed query closed; will
follow that SAE
update submitted
with the info
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880371
Page 142 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct-23-2020 20:19:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered It is clarified that
shortness of breath
is reported in the
initial EA as dyne.
Oct-23-2020 20:10:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Answered It is clarified that the
hospitalization end
date is: 24Sep2020
and the swab date
for SARS-COV-2 is:
20Sep2020. Thank
you.
Oct-22-2020 14:22:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened CLINICAL On
review of the SAE
report for angina, an
event of 'SOB
functional class III'
has been mentioned,
yet it does not
appear on the CRF.
Please review for
safety and update
AE log CRF as
appropriate.
Oct-20-2020 09:57:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 2: Opened Clinical please
submit a SAE safety
update with the End
date of
Hospitalization; the
test date for
SARs-CoV-2 PCR,
and the test date for
Swab SARS-CoV-2
test (SAE lab
section reports 2
COVID tests)
Oct-02-2020 08:52:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE acute
myocardial
infarction: Response
to "Is the adverse
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880372
Page 143 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious 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
Oct-01-2020 13:48:42
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880373
Page 144 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Buenos Aires
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 13:53:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-23-2020 11:31:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-23-2020 11:31:56
(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:
coronary diseaseTranscription Error
Oct-20-2020 15:26:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Reissued:Opened CLINICAL - thank
you for confirming
Angina event is
related to CAD.
Please update Other
reason for Angina
from 'Unknown' to
'CAD'
Oct-19-2020 20:04:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The adverse event
was related to a
history of coronary
disease.
Oct-19-2020 00:04:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened CLINICAL Other
cause for angina
event is Unknown;
however, subject
has a cardiac
disease history with
MI and angioplasty;
please review and
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880374
Page 145 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
update as
appropriate
Oct-01-2020 13:48:42
(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:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020 13:48:42
(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?
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880375
Page 146 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-01-2020 13:48:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880376
Page 147 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-02-2020 08:52:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2020380582Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880377
Page 148 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 11:41:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Oct-22-2020 09:42:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Anxiety CrysisTranscription Error
Oct-22-2020 09:41:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Clarification:
"Dyspnoea" was a
typing error. Form
updated.
Oct-16-2020 11:38:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: COVID-19
listed symptom
DYSPNOEA,
should please have
triggered a COVID
Illness Visit
irrespective of
perceived etiology
or clinical
significance. Please
complete the
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880378
Page 149 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
COVID Illness CRF
forms.
Oct-12-2020 17:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered In the investigator's
discretion, the
episode of dyspnea
was not enough to
consider it a
suspicion of
COVID 19
Oct-12-2020 02:48:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Per protocol
section 8.1.,
COVID-19 listed
symptom
DYSPNOEA,
should please have
triggered a COVID
Illness Visit
irrespective of
perceived etiology
or clinical
significance. Please
complete the
COVID Illness CRF
forms.
Oct-09-2020 08:28:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered According to the
medical history, the
symptoms of AE are
related to an anxiety
crisis and do not
rank as a covid
infection. The
patient has a history
of heart attack.
Thank you
Oct-03-2020 21:22:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: Per protocol
section 8.1.,
COVID-19 listed
symptom
DYSPNOEA,
should please have
triggered a COVID
Illness Visit
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880379
Page 150 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
irrespective of
perceived etiology
or clinical
significance. Please
complete the
COVID Illness CRF
forms.
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
dyspnoeaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/29/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-06-2020 15:18:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query as per
clarification note
dated 05-Oct-2020
Oct-06-2020 10:16:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Correct date is
sep-29
Oct-03-2020 14:08:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened Please clarify end
date of this event, as
medical records HC
EVENTOS
ADVERSOS 2
describe two
diffeent stop dates:
29-Sep and 30-Sep.
Thank you!
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880380
Page 151 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep/29/2020 18:30
6. Toxicity Grade:
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-01-2020 16:45:14
(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-22-2020
09:42:26
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data Entr
y:
NOT REL
ATED
If Not R
elated toNew
Information
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0880381
Page 152 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Oth
er, sp
ecify:
Ang
ina
Pect
oris
Oct-13-2020
05:15:40
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
ClosedResponse
satisfies query
Oct-12-2020
18:42:45
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1:
AnsweredThe
information is
correct, as he
has no history
of distress
Oct-12-2020
12:50:48
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
Opened"If not related
to study
treatment
other" =
anxiety crisis.
Please confirm
if this should
be captured as
an AE or
medhx and
update
accordingly.
Oct-01-2020 ACV0PFEINFP6000  Data Entr Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880382
Page 153 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
16:45:14
(UTC-03:00)
City of
Buenos Airesy:
NOT REL
ATED
If Not R
elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Oth
er, sp
ecify:
anxi
ety
crisi
s
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020 16:45:14 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0880383
Page 154 of 160
***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: 12314035 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-01-2020 16:45:14
(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-01-2020 16:45:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0880384
Page 155 of 160
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 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-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
anxiety crisisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/29/2020 12:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/29/2020 18:30Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880385
Page 156 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
6. Toxicity Grade:
Date Location User Value Reason
Oct-23-2020 20:17:07
(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-23-2020 20:17:07
(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-23-2020 20:17:07
(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-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
Angina pectorisInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880386
Page 157 of 160
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
*** THIS REPEATING FORM HAS BEEN DELETED ***
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-23-2020 20:17:07
(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-23-2020 20:17:07
(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-23-2020 20:17:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (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-2021-5683-0880387
Page 158 of 160
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-03-2021 16:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-03-2021 16:17:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0880388
Page 159 of 160
***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: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-16-2020 15:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020 21:16:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-25-2020 21:14:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-16-2020 15:39:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Aug-25-2020 21:16:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
Aug-25-2020 21:14:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
FDA-CBER-2021-5683-0880389
Page 160 of 160
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
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1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 10:54:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Fernando
PolackData Entry:
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090177e196ae2e64\Final\Final On: 01-Apr-2021 03:11 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0880390