Document text
Page 1 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999636
Page 2 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/15/2020
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999637
Page 3 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12412191]
2.Birth Date: 1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999638
Page 4 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999639
Page 5 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999640
Page 6 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999641
Page 7 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoidal disease]
Start Date: UNK/UNK/1980
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic tension headache]
Start Date: UNK/UNK/1970
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Systemic arterial hypertension]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999642
Page 8 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dyslipidemia]
Start Date: UNK/UNK/2015
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[carotid atherosclerotic disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastroesophageal reflux disease]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999643
Page 9 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999644
Page 10 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
2.Weight: [78.5]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [28.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999645
Page 11 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/15/2020
2.Randomization Number: [269363]
3.Randomization Group: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999646
Page 12 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTSPW]
5.bSample ID [BMM6T7]
5.cSample ID [BMM6T8]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999647
Page 13 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD41X]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999648
Page 14 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/15/2020 08:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999649
Page 15 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999650
Page 16 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999651
Page 17 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999652
Page 18 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BR5TY4]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999653
Page 19 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/6/2020 09:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999654
Page 20 of 200
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999655
Page 21 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7CBM]
5.bSample ID [BS2KH1]
5.cSample ID [BS2KH2]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999656
Page 22 of 200
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999657
Page 23 of 200
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999658
Page 24 of 200
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999659
Page 25 of 200
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999660
Page 26 of 200
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999661
Page 27 of 200
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999662
Page 28 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999663
Page 29 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/12/2020
2.Date of First Symptom Started: Nov/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999664
Page 30 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [Dizziness]
5.bSymptoms - Other Text: [Disorientation]
5.cSymptoms - Other Text: [Transient global amnesia]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999665
Page 31 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of C
ollectionSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Description Device TypeForm Instan
ce
1.Nov/10/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999666
Page 32 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/10/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT unknown]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999667
Page 33 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject used site swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999668
Page 34 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6696]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999669
Page 35 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999670
Page 36 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999671
Page 37 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Hospitalization CategoryHospitalization Ter
mAdmission Dat
eOngoing Form Instance
1.HOSPITALIZATION STATUS
HOSPITAL Nov/9/2020 NO
Discharge Date
:
Nov/12/2020
Repeating Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999672
Page 38 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Nov/9/2020
4.Ongoing? NO
Discharge Date:
Nov/12/2020
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999673
Page 39 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999674
Page 40 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999675
Page 41 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 3
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999676
Page 42 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999677
Page 43 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999678
Page 44 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999679
Page 45 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999680
Page 46 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1. Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999681
Page 47 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999682
Page 48 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999683
Page 49 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999684
Page 50 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999685
Page 51 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999686
Page 52 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessme
ntArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1. Repeating Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999687
Page 53 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999688
Page 54 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999689
Page 55 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999690
Page 56 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999691
Page 57 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999692
Page 58 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/13/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999693
Page 59 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BPTKMF]
5.bSample ID [BRT721]
5.cSample ID [BRT722]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999694
Page 60 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999695
Page 61 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999696
Page 62 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Disorientation to cl
arify Nov/9/2020 UN
K:UNK NO
End Date Time:
Nov/12/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 Vomiting Nov/9/2020 UN
K:UNK NO
End Date Time:
Nov/10/2020 UNK:U
NK
Repeating
Pages
3.ADVERSE E
VENT 3 Dizziness Nov/9/2020 UN
K:UNK NO
End Date Time:
Nov/10/2020 UNK:U
NK
Repeating
Pages
4.ADVERSE E
VENT 4 Transitional global
amnesia Nov/9/2020 UN
K:UNK NO
End Date Time:
Nov/11/2020 UNK:U
NK
Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999697
Page 63 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Disorientation to clarify]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/12/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999698
Page 64 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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:
[to clarify]
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[2020449336]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999699
Page 65 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vomiting]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/10/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999700
Page 66 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
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[ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999701
Page 67 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/10/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999702
Page 68 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
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[ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999703
Page 69 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Transitional global amnesia]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/11/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999704
Page 70 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
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[ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999705
Page 71 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999706
Page 72 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999707
Page 73 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999708
Page 74 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999709
Page 75 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999710
Page 76 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999711
Page 77 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999712
Page 78 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999713
Page 79 of 200
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999714
Page 80 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999715
Page 81 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999716
Page 82 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999717
Page 83 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999718
Page 84 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999719
Page 85 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999720
Page 86 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999721
Page 87 of 200
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999722
Page 88 of 200
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999723
Page 89 of 200
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999724
Page 90 of 200
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999725
Page 91 of 200
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999726
Page 92 of 200
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999727
Page 93 of 200
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999728
Page 94 of 200
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999729
Page 95 of 200
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999730
Page 96 of 200
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/27/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999731
Page 97 of 200
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999732
Page 98 of 200
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999733
Page 99 of 200
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/4/2020
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999734
Page 100 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999735
Page 101 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-12-2021 16:59:20 (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.
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999736
Page 102 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-15-2020 11:12:13 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999737
Page 103 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-12-2021 16:59:20 (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-11-2021 16:13:46 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Feb-02-2021 16:18:22 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-27-2021 15:13:08 (UTC-03:00) City of
Buenos AiresEdit - All
signatures
invalidated
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999738
Page 104 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
N/A
Edson Moreira Approved Jan-22-2021 09:48:02 (UTC-03:00) City of
Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999739
Page 105 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-15-2020 11:11:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-15-2020 11:11:25
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999740
Page 106 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-15-2020 11:11:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Oct/15/2020Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999741
Page 107 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-14-2020
10:46:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies query
Nov-13-2020
13:25:16
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Answered AE CRF was updated.
Thanks!
Nov-13-2020
09:22:41
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020449336
Disorientation to
clarify(onset
date:09Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-15-2020
11:11:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12412191Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-15-2020 11:11:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1955Enrollment Entry
3. Sex:
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999742
Page 108 of 200
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-15-2020 11:11:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-15-2020 11:11:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-15-2020 11:11:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999743
Page 109 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 11:12:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999744
Page 110 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-15-2020 11:12:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 11:12:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 11:12:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999745
Page 111 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Oct-15-2020 11:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Hemorrhoidal
disease
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-15-2020 11:13:56
(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
Nov-15-2020
18:58:45 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Appreciate the
prompt response.
Thank you.
Nov-15-2020
15:15:34 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Query 1: Answered Revised and
updated
Nov-15-2020
14:42:36 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Query 1: Opened Per case narrative,
the subject has a
Med hx of
dyslipidemia from
2015, carotid
atherosclerotic
disease,
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999746
Page 112 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
gastroesophageal
reflux disease.
Please revise and
update this form
accordingly. Thank
you.
Nov-15-2020
13:42:50 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Giselle
CastilloQuery 1: Candidate Per case narrative,
the subject has a
Med hx of
dyslipidemia from
2015, carotid
atherosclerotic
disease,
gastroesophageal
reflux disease.
Please revise and
update this form
accordingly. Thank
you.
Oct-15-2020 11:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Hemorrhoidal diseaseInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-15-2020 11:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-15-2020 11:13:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999747
Page 113 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-15-2020 11:14:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Allergic rhi
nitis
Start Date: UNK/UNK/
2005
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-15-2020 11:14:37
(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-15-2020 11:14:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Allergic rhinitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-15-2020 11:14:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-15-2020 11:14:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999748
Page 114 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Chronic tensio
n headache
Start Date: UNK/UNK/19
70
Ongoing: YESInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999749
Page 115 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Line/MH Number:
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Chronic tension headacheInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-15-2020 11:15:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-15-2020 11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Systemic arteria
l hypertension
Start Date: UNK/UNK/200
5Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999750
Page 116 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-15-2020 11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Systemic arterial hypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-15-2020 11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-15-2020 11:16:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Nov-15-2020 15:12:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:dyslipidemi
aInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999751
Page 117 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Start Date: UNK/UNK/
2015
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Nov-15-2020 15:12:52
(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
Nov-15-2020 15:12:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
dyslipidemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-15-2020 15:12:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-15-2020 15:12:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Nov-15-2020 15:13:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999752
Page 118 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Medical Hist
ory Term:carotid atheroscl
erotic disease
Start Date: UNK/UNK/201
5
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Nov-15-2020 15:13:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-15-2020 15:13:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
carotid atherosclerotic diseas
eInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-15-2020 15:13:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-15-2020 15:13:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Nov-15-2020 15:14:44 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999753
Page 119 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos Aires(autocalc) Line/MH Nu
mber:7
Medical Hist
ory Term:gastroesophagea
l reflux disease
Start Date: UNK/UNK/200
0
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Nov-15-2020 15:14:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-15-2020 15:14:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
gastroesophageal reflux disea
seInitial Entry
1.g Start Date:
Date Location User Value Reason
Nov-15-2020 15:14:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.g Ongoing:
Date Location User Value Reason
Nov-15-2020 15:14:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999754
Page 120 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-15-2020 11:19:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999755
Page 121 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
78.5Initial Entry
3. Unit:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999756
Page 122 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.8Initial Entry
7.a
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.4
Temperature U
nit:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999757
Page 123 of 200
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-15-2020 11:20:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999758
Page 124 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-15-2020 11:21:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-15-2020 11:21:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
269363Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999759
Page 125 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 08:31:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 08:31:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 08:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 08:31:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 08:31:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999760
Page 126 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-16-2020 08:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTSPWInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 08:31:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTSPWInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 08:31:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BMM6T7Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 08:31:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BMM6T7Initial Entry
5.c
Date Location User Value Reason
Oct-16-2020 08:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BMM6T8Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 08:32:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BMM6T8Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999761
Page 127 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 07:21:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 07:21:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 07:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 07:21:21
(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.
Oct-16-2020 07:21:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999762
Page 128 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-16-2020 07:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRD41XInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 07:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRD41XInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999763
Page 129 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Oct/15/2020 08:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999764
Page 130 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-15-2020 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999765
Page 131 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-15-2020 11:21:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999766
Page 132 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-19-2020 03:28:56
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-18-2020 08:38:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered This alert refers to
the Covid visit of
12Nov2020
Nov-18-2020 03:56:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Reissued:Opened RQ1: Thank you
for the response.
Please consider to
follow-up and
confirm for
reported Illness
eDiary response on
13NOV2020.
Please update or
clarify.
Nov-17-2020 10:43:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered The subject was
asked by the site to
make the
notification, which
only occurred after
Covid's visit
Nov-17-2020 08:00:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened Illness ediary: As
per Illness ediary
records, subject
reported "Yes" for
the COVID-19
symptoms or
diagnosis on
13NOV2020. But
no corresponding
COVID Illness
visit indicate
symptoms present
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999767
Page 133 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
at this date. Pls
update Covid
illness visit or
clarify.
Nov-06-2020 10:15:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999768
Page 134 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-06-2020 10:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
2.a
Date Location User Value Reason
Nov-06-2020 10:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.4
Temperature U
nit:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-06-2020 10:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-06-2020 10:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999769
Page 135 of 200
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-06-2020 10:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-06-2020 10:15:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999770
Page 136 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 11:07:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 11:07:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 11:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 11:07:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-06-2020 11:07:57
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999771
Page 137 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-06-2020 11:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR5TY4Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 11:08:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR5TY4Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999772
Page 138 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/6/2020 09:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999773
Page 139 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-06-2020 10:16:14
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999774
Page 140 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-04-2020 11:19:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/4/2020Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999775
Page 141 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020 13:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020 13:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-04-2020 13:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-04-2020 13:54:17
(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.
Dec-04-2020 13:54:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999776
Page 142 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-04-2020 13:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR7CBMInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020 13:54:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR7CBMInitial Entry
5.b
Date Location User Value Reason
Dec-04-2020 13:54:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS2KH1Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020 13:54:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS2KH1Initial Entry
5.c
Date Location User Value Reason
Dec-04-2020 13:54:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BS2KH2Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-04-2020 13:54:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BS2KH2Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999777
Page 143 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-24-2020
06:58:01
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Closed Closed as data
entered.
Dec-23-2020
11:16:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Answered data updated
Dec-23-2020
10:16:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 4: Opened DM: Kindly
review and
complete
‘Hospitalization
Details form' at
this visit. Thank
you.
Nov-17-2020
09:11:11 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-16-2020
15:27:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Answered data updated
Nov-16-2020
07:22:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 3: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen Illness
Details form' at
this visit. Thank
you.
Nov-13-2020 ACV0PFEINFP6000 auto query Query 1: Deleted Close Auto Query
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999778
Page 144 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
14:17:11
(UTC-03:00) City of
Buenos Aires(autoquery)
Nov-13-2020
14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-13-2020
14:12:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-13-2020
14:12:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Nov-13-2020
14:12:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-13-2020 14:12:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999779
Page 145 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-23-2020 09:43:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-22-2020 09:55:52
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered data updated
Dec-21-2020 17:01:33
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per source
data, participant
reported other
symptoms as
disorientation and
transient global
amnesia. Please
review source data
and consider
update information
as applicable.
Nov-13-2020 14:18:53 ACV0PFEINFP6000 Data Entry: Transcription
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0999780
Page 146 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresNO
Date of Last Symptom Res
olved:
Nov/10/2020Error
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999781
Page 147 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.b Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Pres
ent:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999782
Page 148 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.d
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE P
AIN
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999783
Page 149 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.e Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999784
Page 150 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.g
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE THR
OAT
Sympto
m Prese
nt:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999785
Page 151 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.h Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:YESInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-13-2020 14:13:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
5.a
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999786
Page 152 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-13-2020 14:14:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Other
:Dizzines
sInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-13-2020 14:14:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DizzinessInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 11:36:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Ot
her:Disorientat
ionTranscription
Error
Dec-22-2020 09:55:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms - Ot
her:Desorientat
ionInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999787
Page 153 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b Symptoms - Other Text:
Date Location User ValueReason
Dec-22-2020
12:54:02
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Dec-22-2020
11:36:38
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Dec-22-2020
11:36:38
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Disori
entati
onTranscription Error
Dec-22-2020
10:52:04
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify
DESORIENTATION
as follows...Should
the spelling be
DISORIENTATION?
If so, edit. Otherwise
clarify. Thank you.
Dec-22-2020
09:55:18
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000 Data
Entry
:
Desor
ientati
onInitial Entry
5.c
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999788
Page 154 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-22-2020 09:55:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Symptoms -
Other:Transient globa
l amnesiaInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-22-2020 09:55:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Transient global amnesiaInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999789
Page 155 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999790
Page 156 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
6. Trade Name:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999791
Page 157 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-16-2020 15:27:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NALT unknownInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999792
Page 158 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 14:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 14:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 14:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-13-2020 14:16:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Subject used site swabInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999793
Page 159 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 14:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 14:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 14:17:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 14:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-13-2020 14:17:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999794
Page 160 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-13-2020 14:17:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BR6696Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 14:17:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BR6696Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999795
Page 161 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitione
r:SPECI
ALIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:EMERGENC
Y ROOM
Occurrence o
f Visits or Co
ntacts:YES
Number of V
isits or Cont
acts:
1Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999796
Page 162 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts
:
1Initial Entry
1.c
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999797
Page 163 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practition
er:URGEN
T CARE
Occurrence of Vis
its or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999798
Page 164 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999799
Page 165 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Dec-23-2020 09:42:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-22-2020 09:57:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Dec-22-2020 09:57:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Has the subject been in inte
nsive care due to potential
COVID-19 illness?
YESNew Information
Dec-21-2020 16:51:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened As per source
data, participant
was in intensive
care due to
potential covid-19
illness from
09Nov2020 to
12Nov2020, SAE
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999800
Page 166 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2020449336
reported. Please
review source
documents and
consider update
information as
applicable. CRF
section 8.35 for
reference.
Nov-13-2020 14:18:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999801
Page 167 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-23-2020 11:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999802
Page 168 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Dec-23-2020 11:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Dec-23-2020 11:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Mar-12-2021 15:01:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Opened CLIQUERY:
Hospitalization:
This subject had
COVID-19 Illness
and was
hospitalized. Please
enter any available
information (vital
signs, pulse
oxymet, respiratory
treatment, lab
results,
imaging…). Please
make every effort
to obtain these
information.
Dec-23-2020 11:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
4. Ongoing?
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999803
Page 169 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Dec-23-2020 11:16:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Nov/12/2020Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999804
Page 170 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/12/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-16-2020 13:48:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-16-2020 13:48:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-16-2020 13:48:20
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999805
Page 171 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/13/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/13/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-13-2021 11:21:28
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999806
Page 172 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 13:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 13:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 13:53:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 13:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-13-2021 13:53:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999807
Page 173 of 200
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Jan/13/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Jan-13-2021 13:53:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPTKMFInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 13:53:13
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BPTKMFInitial Entry
5.b
Date Location User Value Reason
Jan-13-2021 13:54:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRT721Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-13-2021 13:54:29
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRT721Initial Entry
5.c
Date Location User Value Reason
Jan-13-2021 13:54:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRT722Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-13-2021 13:54:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
BRT722Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999808
Page 174 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999809
Page 175 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999810
Page 176 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999811
Page 177 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999812
Page 178 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-13-2020 13:23:44
(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
Feb-25-2021
13:11:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 2: Closed Escalated to CRA
Feb-19-2021
16:07:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered Diagnosis not
available. Subject is
under evaluation with
neurologist.
Jan-15-2021
12:05:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 2: Reissued:Open
edThanks for
confirming. Please
make every effort
possible to obtain
further information
and respond to the
query once additional
information is
available.
Jan-15-2021
10:07:06
(UTC-03:00) City ofACV0PFEINFP6000 Query 2: Answered Subject attended to
visit the ite on
13Jan2021 but to
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999813
Page 179 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires close the event
depends on the result
of magnetic
resonance that is
scheduled for
16Jan2021
Dec-23-2020
20:37:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 2: Reissued:Open
edKindly clarify if the
disorientation was a
symptom of the
transition global
amnesia, was the later
considered the final
diagnosis? If so,
please consider
updating AE to final
diagnosis.
Dec-23-2020
10:41:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 2: Answered All symptoms
reported to safety
(dizziness, vomiting,
transitional global
amnesia) are related
to AE "Disorientation
to clarify". Is not
consider new AE.
Dec-15-2020
12:24:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 2: Opened Per SAE report
submitted to safety,
the subject has a
specific diagnosis of
"Transitional global
amnesia". Kindly
revise as an additional
AE and update the
log accordingly.
Thank you
Dec-15-2020
12:20:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 1: Closed I am closing due to a
new query being
issued.
Dec-03-2020 ACV0PFEINFP6000 Giselle Castillo Query 1: Reissued:Open Appreciate the
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999814
Page 180 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
17:02:16
(UTC-03:00) City of
Buenos Airesed response. Kindly
further elaborate on
the reason for the lack
of diagnosis. Please
make every effort to
obtain these
information. Thank
you.
Dec-03-2020
15:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered DIAGNOSIS NOT
AVAILABLE
Nov-25-2020
13:16:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 1: Reissued:Open
edThanks for
confirming. Please
respond to the query
once additional
information is
available. Thanks
Nov-24-2020
15:30:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered A FOLLOW UP
REPORT WAS SENT
TO SAFETY WITH
THE RESULT FOR
SARS-COV-2 AS
NOT DETECTED
ON 17NOV2020.
DIAGNOSIS NOT
AVAILABLE UNTIL
THE PRESENT
MOMENT.
Nov-20-2020
20:07:51
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Giselle Castillo Query 1: Opened Per case narrative,
"The diagnosis of the
SAE was pending,
and it was suspected
as SARS-COV2 or
ischemic
cerebrovascular
disease or viral
meningoencephalitis."
Kindly provide
current diagnosis and
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999815
Page 181 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
submit FU report with
updated information.
Thank you.
Nov-13-2020
13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Disorientation to clarifyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/12/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-13-2020 13:23:44
(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
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999816
Page 182 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-14-2020
10:44:39 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020
13:23:44 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Disorientation to
clarify: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-13-2020
13:23:44 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000 Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically importantInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999817
Page 183 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to
:
OTHER
If Other, specify:
to clarifyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999818
Page 184 of 200
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-13-2020 13:23:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-14-2020 10:44:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
2020449336Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999819
Page 185 of 200
***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, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 16:13:46
(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-12-2021 11:43:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Per Prot Sect
8.3.7., COVID-19
listed symptoms
VOMITING does
not qualify as AE
and please should
be documented
only on the
COVID-19 Illness
CRF SOD form
(already entered)
and should not be
captured on the
AE CRF page
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
VomitingInitial Entry
4. Start Date Time:
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999820
Page 186 of 200
***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, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/10/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 16:14:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
3Transcription
Error
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
4Initial 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-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999821
Page 187 of 200
***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, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Mar-11-2021 16:13:46
(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-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999822
Page 188 of 200
***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, Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 16:13:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999823
Page 189 of 200
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
DizzinessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/10/2020 UNK:UNKInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999824
Page 190 of 200
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 16:17:06
(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-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 16:17:06
(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-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999825
Page 191 of 200
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 16:17:06
(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-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 16:17:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999826
Page 192 of 200
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Transitional global amnesiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Nov/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/11/2020 UNK:UNKInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999827
Page 193 of 200
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 16:19:09
(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-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 16:19:09
(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-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999828
Page 194 of 200
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 16:19:09
(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-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 16:19:09
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (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-2021-5683-0999829
Page 195 of 200
***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, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-04-2020 11:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Dec/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-04-2020 11:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-04-2020 11:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999830
Page 196 of 200
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 15:13:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999831
Page 197 of 200
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-27-2021 15:13:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible and NOT confir
med to have received onl
y placebo at Vaccination
1/2Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999832
Page 198 of 200
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-27-2021 15:13:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
Jan/27/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021 15:13:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FO
R ADDITIONAL VACCIN
ATIONInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999833
Page 199 of 200
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-04-2020 11:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-15-2020 11:21:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-15-2020 11:12:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-04-2020 11:19:48
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/4/2020Initial Entry
Oct-15-2020 11:21:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Oct-15-2020 11:12:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999834
Page 200 of 200
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412191 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-22-2021 09:47:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Edson
MoreiraData Entry:
Click Here to EnableInitial Entry
090177e196ae3f51\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999835