125742 S1 M5 CRF c4591001 1231 12314690

Document text

Page 1 of 159
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885326
Page 2 of 159
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/28/2020
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885327
Page 3 of 159
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Demography
1.Subject ID [12314690]
2.Birth Date: 1960
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885328
Page 4 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885329
Page 5 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885330
Page 6 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885331
Page 7 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:[Dyslipidemia]
Start Date: Jan/1/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastro esophageal Reflux]
Start Date: Jul/15/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hiatal hernia]
Start Date: Jul/15/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[uterine myoma]
Start Date: Jul/UNK/2019
Ongoing: YES
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885332
Page 8 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:[left ovarian cyst]
Start Date: Jul/UNK/2019
Ongoing: YES
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885333
Page 9 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [60.0]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [21.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885334
Page 10 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885335
Page 11 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [244251]
3.Randomization Group: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885336
Page 12 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/28/2020
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 [BLC5LK]
5.bSample ID [BLC5LL]
5.cSample ID [BLC5LM]
5.dSample ID [BPTCX6]
5.eSample ID [BPTCX7]
5.fSample ID [BPTCX8]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885337
Page 13 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/28/2020
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 [BPTDJB]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885338
Page 14 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/28/2020 10:15
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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885339
Page 15 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885340
Page 16 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885341
Page 17 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885342
Page 18 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885343
Page 19 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2BC3]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885344
Page 20 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 12:21
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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885345
Page 21 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885346
Page 22 of 159
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/20/2020
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 [BNV7LM]
5.bSample ID [BNV7MK]
5.cSample ID [BPWDN5]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885347
Page 23 of 159
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885348
Page 24 of 159
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_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: 12314690 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 [BP1WY3]
5.bSample ID [BS1VY2]
5.cSample ID [BS1PZ4]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885349
Page 25 of 159
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885350
Page 26 of 159
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885351
Page 27 of 159
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885352
Page 28 of 159
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885353
Page 29 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885354
Page 30 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 28-Mar-2021 02:35 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885355
Page 31 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885356
Page 32 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885357
Page 33 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 28-Mar-2021 02:23 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885358
Page 34 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885359
Page 35 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885360
Page 36 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885361
Page 37 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885362
Page 38 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Unplanned Assessments
1.Assessments
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885363
Page 39 of 159
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885364
Page 40 of 159
***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: 12314690 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: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885365
Page 41 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885366
Page 42 of 159
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885367
Page 43 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885368
Page 44 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885369
Page 45 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885370
Page 46 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885371
Page 47 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885372
Page 48 of 159
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885373
Page 49 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885374
Page 50 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885375
Page 51 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885376
Page 52 of 159
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885377
Page 53 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885378
Page 54 of 159
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885379
Page 55 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  exacerbation of gastroesopha
geal reflux Oct/1/2020 0
8:00 NO
End Date Time:
Oct/29/2020 16:00
 Repeating
Pages
 2.ADVERSE E
VENT 2  Signetringcellgastriccarcino
ma(SRCGC) Jan/29/2021
16:30 YES  Repeating
Pages
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885380
Page 56 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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)[exacerbation of gastroesophageal reflux]
4.Start Date Time: Oct/1/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 16:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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:
[chronic antral ulcer]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885381
Page 57 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? 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[ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885382
Page 58 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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)[Signetringcellgastriccarcinoma(SRCGC)]
4.Start Date Time: Jan/29/2021 16:30
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885383
Page 59 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021318492]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885384
Page 60 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885385
Page 61 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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[ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885386
Page 62 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885387
Page 63 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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: //
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885388
Page 64 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885389
Page 65 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885390
Page 66 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885391
Page 67 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885392
Page 68 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885393
Page 69 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885394
Page 70 of 159
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885395
Page 71 of 159
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885396
Page 72 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885397
Page 73 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885398
Page 74 of 159
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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: [ ]
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885399
Page 75 of 159
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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/20/2020
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885400
Page 76 of 159
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885401
Page 77 of 159
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885402
Page 78 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-28-2020 11:54:50 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885403
Page 79 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormAug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885404
Page 80 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
1Aug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885405
Page 81 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
2Aug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885406
Page 82 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
3Aug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885407
Page 83 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
4Aug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885408
Page 84 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
5Aug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885409
Page 85 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6.aAug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885410
Page 86 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6.aAug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885411
Page 87 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6.aAug-28-2020 11:55:47 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885412
Page 88 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
FormSep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885413
Page 89 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
1Sep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885414
Page 90 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
2Sep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885415
Page 91 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
3Sep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885416
Page 92 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
4Sep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885417
Page 93 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
5Sep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885418
Page 94 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6.aSep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885419
Page 95 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6.aSep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885420
Page 96 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
ItemDate User Comment
6.aSep-18-2020 19:01:06 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885421
Page 97 of 159
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-29-2021 11:18:23 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-24-2021 17:00:14 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-22-2021 16:56:05 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Maria Beretta  Approved Feb-08-2021 17:23:08 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885422
Page 98 of 159
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Affidavit:
By my dated signature below, I, MariaBeretta, 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-04-2021 10:35:12 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Santiago
Corradetti Approved Nov-08-2020 16:52:05 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, SantiagoCorradetti, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-07-2020 16:23:14 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Fernando
Polack Approved Oct-30-2020 20:32:50 (UTC-03:00) City of
Buenos AiresBOOK Signed
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885423
Page 99 of 159
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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.
 N/A Oct-30-2020 18:26:07 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 22:35:04 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885424
Page 100 of 159
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-28-2020 11:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 11:54:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885425
Page 101 of 159
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 11:54:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885426
Page 102 of 159
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 10:03:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12314690Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 10:03:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 11:54:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 11:54:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 11:54:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885427
Page 103 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-28-2020 11:54:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885428
Page 104 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-28-2020 11:55:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 11:55:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 11:55:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885429
Page 105 of 159
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 11:55:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Dyslipidem
ia
Start Date: Jan/1/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 11:55:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 11:55:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DyslipidemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 11:55:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/1/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 11:55:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885430
Page 106 of 159
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.b
Date Location User Value Reason
Oct-30-2020 18:26:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Gastro esophage
al Reflux
Start Date: Jul/15/2015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-30-2020 18:26:07
(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-30-2020 18:26:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Gastro esophageal RefluxInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-30-2020 18:26:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jul/15/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-30-2020 18:26:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885431
Page 107 of 159
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Mar-29-2021 11:18:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Number
:3
Medical History T
erm:hiatal her
nia
Start Date: Jul/15/20
15
Ongoing: YESNew Information
Mar-29-2021 11:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:hiatal hernia
Start Date: Jul/15/2015
Ongoing: NO
End Date:
Nov/27/
2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885432
Page 108 of 159
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
1.c Line/MH Number:
Date Location User Value Reason
Mar-29-2021 11:18:23
(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
Mar-29-2021 11:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
hiatal herniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Mar-29-2021 11:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jul/15/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Mar-29-2021 11:18:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESNew Information
Mar-29-2021 11:18:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/27/2020Initial Entry
1.d
Date Location User Value Reason
Mar-29-2021 11:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:uterine myo
maInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885433
Page 109 of 159
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Start Date: Jul/UNK/20
19
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Mar-29-2021 11:19:30
(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
Mar-29-2021 11:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
uterine myomaInitial Entry
1.d Start Date:
Date Location User Value Reason
Mar-29-2021 11:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jul/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Mar-29-2021 11:19:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Mar-29-2021 11:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:left ovarian c
yst
Start Date: Jul/UNK/201
9Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885434
Page 110 of 159
***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, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Mar-29-2021 11:19:55
(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
Mar-29-2021 11:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
left ovarian cystInitial Entry
1.e Start Date:
Date Location User Value Reason
Mar-29-2021 11:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jul/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Mar-29-2021 11:19:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885435
Page 111 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
60.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885436
Page 112 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.0Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 37.0
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
37.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 11:55:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 11:55:37 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (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-2021-5683-0885437
Page 113 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00) City of
Buenos AiresORAL CAVITY
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885438
Page 114 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (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-2021-5683-0885439
Page 115 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-28-2020 11:55:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885440
Page 116 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 11:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 11:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
244251Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885441
Page 117 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 11:56:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 11:56:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 19:36:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 11:56:08
(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-28-2020 11:56:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 19:36:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLC5LKInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885442
Page 118 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Aug-29-2020 19:36:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLC5LKInitial Entry
5.b
Date Location User Value Reason
Aug-29-2020 19:37:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLC5LLInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-29-2020 19:37:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLC5LLInitial Entry
5.c
Date Location User Value Reason
Aug-29-2020 19:37:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BLC5LMInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-29-2020 19:37:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BLC5LMInitial Entry
5.d
Date Location User Value Reason
Aug-30-2020 14:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BPTCX6Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885443
Page 119 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.d Sample ID
Date Location User Value Reason
Aug-30-2020 14:29:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPTCX6Initial Entry
5.e
Date Location User Value Reason
Aug-30-2020 14:29:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BPTCX7Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-30-2020 14:29:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPTCX7Initial Entry
5.f
Date Location User Value Reason
Aug-30-2020 14:29:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
Sample ID: BPTCX8Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-30-2020 14:29:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Maria del
Pilar PereyraData Entry:
BPTCX8Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885444
Page 120 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 11:56:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 11:56:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-29-2020 12:47:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 11:56:16
(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-28-2020 11:56:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-29-2020 12:47:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPTDJBInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885445
Page 121 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Aug-29-2020 12:47:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPTDJBInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885446
Page 122 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-28-2020 11:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 11:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 11:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 11:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Aug/28/2020 10:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 11:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885447
Page 123 of 159
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Aug-28-2020 11:56:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020 11:56:25
(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-28-2020 11:56:25
(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-28-2020 11:56:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885448
Page 124 of 159
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-28-2020 11:56:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885449
Page 125 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 19:00:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885450
Page 126 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.9
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885451
Page 127 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 19:00:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885452
Page 128 of 159
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (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-2021-5683-0885453
Page 129 of 159
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-18-2020 19:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885454
Page 130 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 15:44:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 15:44:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 15:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 15:44:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 15:44:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 15:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP2BC3Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885455
Page 131 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 15:44:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP2BC3Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885456
Page 132 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sep/16/2020 12:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885457
Page 133 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 19:01:21
(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-18-2020 19:01:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885458
Page 134 of 159
***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: 12314690 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-20-2020 10:04:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885459
Page 135 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 10:04:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 10:04:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 12:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-20-2020 10:39:32
(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.
Oct-20-2020 10:04:40
(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-20-2020 10:04:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885460
Page 136 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a
Date Location User Value Reason
Oct-20-2020 12:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV7LMInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 12:12:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV7LMInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BNV7MKInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 13:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BNV7MKInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BPWDN5Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0885461
Page 137 of 159
***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: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 13:37:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BPWDN5Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885462
Page 138 of 159
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 16:56:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/22/2021Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885463
Page 139 of 159
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 16:56:21
(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 16:56:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-23-2021 09:12:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-22-2021 16:56:21
(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 16:56:21
(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-23-2021 09:12:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
Sample ID: BP1WY3Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885464
Page 140 of 159
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
5.a Sample ID
Date Location User Value Reason
Mar-23-2021 09:12:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Alan Colombo Data Entry:
BP1WY3Initial Entry
5.b
Date Location User Value Reason
Mar-23-2021 09:53:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1VY2Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-23-2021 09:53:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1VY2Initial Entry
5.c
Date Location User Value Reason
Mar-23-2021 12:54:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS1PZ4Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-23-2021 12:54:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS1PZ4Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0885465
Page 141 of 159
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-20-2020 10:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 10:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 10:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885466
Page 142 of 159
***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, Locked, Frozen, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-04-2021 10:35:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885467
Page 143 of 159
***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, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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-04-2021 10:35:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885468
Page 144 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885469
Page 145 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885470
Page 146 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-20-2020 10:01:42
(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 Value Reason
Nov-07-2020 16:23:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
exacerbation of gastroesophageal
refluxNew Information
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Flare-up of Gastroesophageal Ref
luxInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/1/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-07-2020 16:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:New Information
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885471
Page 147 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oct/29/2020 16:00
Oct-30-2020 14:00:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-30-2020 13:52:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered The AE is ongoing.
Thank you
Oct-30-2020 13:29:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if AE
'Flare-up of
Gastroesophageal
Reflux'has resolved
or is still ongoing. If
RESOLVED, please
update AE Record
and enter END date.
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (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-2021-5683-0885472
Page 148 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-07-2020
16:24:00
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
If
Oth
er,
spe
cify
:
c
hr
o
ni
c
a
nt
ra
lNew Information
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885473
Page 149 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
ul
ce
r
Nov-02-2020
14:57:08
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: ClosedResponse satisfies
query
Nov-02-2020
10:51:42
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2
: ClosedResponse satisfies
query
Nov-02-2020
09:15:43
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Tatiana Estrada Query 1
: Answe
redmedical history
was already
updated with
history of gastro
esophageal
reflux.thank you
Oct-31-2020
10:03:03
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Reissu
ed:Open
edDM: Any
symptoms, AEs or
other key data
should be
collected on the
appropriate page.
Please review and
update as
necessary
Oct-30-2020
18:28:44
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 1
: Answe
redOriginal value is
correct
Oct-30-2020
18:27:58
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Query 2
: Answe
redChanged data per
query
Oct-30-2020
13:27:49ACV0PFEINFP6000  Query 2
: OpeneClinQuery: Please
update Medical
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885474
Page 150 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
(UTC-03:00)
City of
Buenos Airesd History record
and enter history
of Gastro
esophageal Reflux
as noted on the
AE record.
Oct-30-2020
06:58:24
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1
: Opene
dPlease review "If
not related to
study treatment
other" field, the
following text was
indicated in the
comment field
[Gastroesophageal
Reflux]. Any
symptoms, AEs or
other key data
should be
collected on the
appropriate page.
Please review and
update as
necessary.
Oct-20-2020
10:01:42
(UTC-03:00)
City of
Buenos AiresACV0PFEINFP6000  Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
IfInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0885475
Page 151 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Oth
er,
spe
cify
:
H
is
to
ry
of
G
as
tr
o
es
o
p
h
a
g
ea
l
R
ef
lu
x
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885476
Page 152 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-07-2020 16:26:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-07-2020 16:26:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Nov-07-2020 16:25:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE exacerbation
of gastroesophageal
reflux: Response to
"What was the
outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time
is present.
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-20-2020 10:01:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885477
Page 153 of 159
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Category:
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-23-2021 10:20:27
(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
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Signetringcellgastriccarcinoma(SR
CGC)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/29/2021 16:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885478
Page 154 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Mar-23-2021 10:20:27
(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
Mar-24-2021
06:20:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-23-2021
10:20:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Signetringcellgastriccarcinoma(SRCGC):
Response to "Is the adverse event
serious?" is 'Yes' but "Serious Adverse
Event Number" is blank.
Mar-23-2021
10:20:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anoma
ly or birth defect?
NO
Did this serious e
vent result in deat
h?
NO
Did this serious e
vent require or pr
olong hospitalizat
ion?
NOInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885479
Page 155 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Did this serious e
vent result in pers
istent or significa
nt disability/incap
acity?
NO
Is this serious eve
nt life threatening
?
NO
Other medically i
mportant serious
event
YES
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
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-23-2021 10:20:27
(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:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0885480
Page 156 of 159
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-23-2021 10:20:27
(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
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-23-2021 10:20:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-24-2021 06:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
2021318492Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (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-2021-5683-0885481
Page 157 of 159
***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: 12314690 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-04-2021 10:35:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 10:35:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0885482
Page 158 of 159
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 20:34
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-20-2020 10:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 11:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 11:55:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020 10:05:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Aug-28-2020 11:55:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020 11:55:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4)
FDA-CBER-2021-5683-0885483
Page 159 of 159
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme
Argerich
Subject No: 12314690 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 22:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2ed0\Final\Final On: 01-Apr-2021 03:24 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0885484