125742 S1 M5 CRF c4591001 1241 12412190

Document text

Page 1 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999424
Page 2 of 212
***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: 12412190 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/14/2020
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999425
Page 3 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12412190]
2.Birth Date: 1970
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999426
Page 4 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999427
Page 5 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999428
Page 6 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999429
Page 7 of 212
***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: 12412190 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:[Hysterectomy]
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2019
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy Acetyl salicylic acid]
Start Date: UNK/UNK/1984
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dipyrone allergy]
Start Date: UNK/UNK/1984
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sulfa allergy]
Start Date: UNK/UNK/1984
Ongoing: YES
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999430
Page 8 of 212
***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: 12412190 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:[Non-steroidal anti-inflammatory allergy]
Start Date: UNK/UNK/1984
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Psoriasis]
Start Date: UNK/UNK/1985
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine fibroid]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/1984
Ongoing: YES
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999431
Page 9 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prosthesis insertion in left arm]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999432
Page 10 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999433
Page 11 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
2.Weight: [90.0]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [32.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999434
Page 12 of 212
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999435
Page 13 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/14/2020
2.Randomization Number: [107634]
3.Randomization Group: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999436
Page 14 of 212
***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: 12412190 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/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD429]
5.bSample ID [BMM6SF]
5.cSample ID [BMM6SG]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999437
Page 15 of 212
***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: 12412190 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/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD41T]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999438
Page 16 of 212
***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: 12412190 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/14/2020 15:54
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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999439
Page 17 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999440
Page 18 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999441
Page 19 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999442
Page 20 of 212
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999443
Page 21 of 212
***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: 12412190 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/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 [BR79J0]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999444
Page 22 of 212
***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: 12412190 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/4/2020 12:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999445
Page 23 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/3/2020
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999446
Page 24 of 212
***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: 12412190 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/3/2020
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 [BR7C8H]
5.bSample ID [BS2KBS]
5.cSample ID [BS2KBT]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999447
Page 25 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999448
Page 26 of 212
***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: 12412190 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 [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999449
Page 27 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999450
Page 28 of 212
***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: 12412190 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 [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999451
Page 29 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999452
Page 30 of 212
***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: 12412190 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 [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999453
Page 31 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999454
Page 32 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/24/2020
2.Date of First Symptom Started: Nov/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999455
Page 33 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Fatigue]
5.cSymptoms - Other Text: [Nausea]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999456
Page 34 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Instan
ce
 1.Nov/25/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999457
Page 35 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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/25/2020
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: ROCHE MOLECULAR SYSTEMS COBAS SARS-COV-2
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999458
Page 36 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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? YES
Date of Collection:
Nov/24/2020
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 [RR03345]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999459
Page 37 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject used self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999460
Page 38 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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:NO
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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999461
Page 39 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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?NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999462
Page 40 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999463
Page 41 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999464
Page 42 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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: 1
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999465
Page 43 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999466
Page 44 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999467
Page 45 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999468
Page 46 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999469
Page 47 of 212
***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: 12412190 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-Define
d IdentifierTes
t:Res
ult:Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999470
Page 48 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999471
Page 49 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999472
Page 50 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999473
Page 51 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999474
Page 52 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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 % [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999475
Page 53 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.      Repeating Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999476
Page 54 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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):[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999477
Page 55 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999478
Page 56 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999479
Page 57 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999480
Page 58 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999481
Page 59 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/22/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999482
Page 60 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/22/2020Form: 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: 12412190 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/22/2020
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 [BR796M]
5.bSample ID [BS2JTH]
5.cSample ID [BS2JTJ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999483
Page 61 of 212
***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: 12412190 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:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999484
Page 62 of 212
***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: 12412190 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 [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999485
Page 63 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Left armpit lymph nod
e enlargement Oct/15/2020 U
NK:UNK NO
End Date Time:
Oct/16/2020 UNK:U
NK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Pain in prosthesis in th
e left hand Oct/15/2020 U
NK:UNK NO
End Date Time:
Oct/30/2020 UNK:U
NK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Pain in prosthesis in th
e left hand Nov/5/2020 U
NK:UNK NO
End Date Time:
Nov/7/2020 UNK:U
NK
 Repeating
Pages
 4.ADVERSE
EVENT 4  Fever  Nov/5/2020 U
NK:UNK NO
End Date Time:
Nov/6/2020 UNK:U
NK
 Repeating
Pages
 5.ADVERSE
EVENT 5  chills  Nov/5/2020 U
NK:UNK NO
End Date Time:
Nov/6/2020 UNK:U
NK
 Repeating
Pages
 6.ADVERSE
EVENT 6  Fatigue  Nov/5/2020 U
NK:UNK NO
End Date Time:
Nov/6/2020 UNK:U
NK
 Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999486
Page 64 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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)[Left armpit lymph node enlargement]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/16/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999487
Page 65 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999488
Page 66 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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)[Pain in prosthesis in the left hand]
4.Start Date Time: Oct/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/30/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999489
Page 67 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999490
Page 68 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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)[Pain in prosthesis in the left hand]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999491
Page 69 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999492
Page 70 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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)[Fever]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999493
Page 71 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999494
Page 72 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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: [5]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[chills]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999495
Page 73 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999496
Page 74 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 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: [6]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Fatigue]
4.Start Date Time: Nov/5/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999497
Page 75 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999498
Page 76 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Stil
l OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999499
Page 77 of 212
***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: 12412190 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[ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999500
Page 78 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999501
Page 79 of 212
***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: 12412190 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: //
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999502
Page 80 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999503
Page 81 of 212
***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: 12412190 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?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999504
Page 82 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999505
Page 83 of 212
***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: 12412190 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?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999506
Page 84 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999507
Page 85 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999508
Page 86 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999509
Page 87 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999510
Page 88 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999511
Page 89 of 212
***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: 12412190 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:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999512
Page 90 of 212
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999513
Page 91 of 212
***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: 12412190 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?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999514
Page 92 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999515
Page 93 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999516
Page 94 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999517
Page 95 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999518
Page 96 of 212
***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: 12412190 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 [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999519
Page 97 of 212
***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: 12412190 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 [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999520
Page 98 of 212
***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: 12412190 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/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999521
Page 99 of 212
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999522
Page 100 of 212
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999523
Page 101 of 212
***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: 12412190 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: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999524
Page 102 of 212
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999525
Page 103 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999526
Page 104 of 212
***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: 12412190 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: [ ]
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999527
Page 105 of 212
***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: 12412190 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/3/2020
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999528
Page 106 of 212
***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: 12412190 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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999529
Page 107 of 212
***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: 12412190 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
Edson
Moreira Approved Jan-22-2021 09:47:30 (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.
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999530
Page 108 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormOct-14-2020 17:03:19 (UTC-03:00) City of
Buenos AiresNot Applicable
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999531
Page 109 of 212
***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: 12412190 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
Edson
Moreira Approved Jan-22-2021 09:47:30 (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.
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999532
Page 110 of 212
***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: 12412190 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-14-2020 17:02:35
(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-14-2020 17:02:35
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999533
Page 111 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-14-2020 17:02:44
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Oct/14/2020Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999534
Page 112 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-14-2020 17:02:26
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12412190Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-14-2020 17:02:22
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-14-2020 17:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-14-2020 17:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-14-2020 17:02:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999535
Page 113 of 212
***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: 12412190 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-14-2020 17:03:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999536
Page 114 of 212
***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: 12412190 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-14-2020 17:03:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 17:03:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020 17:03:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999537
Page 115 of 212
***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: 12412190 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 17:00:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Hysterectom
y
Start Date: Oct/UNK/2
019
Ongoing: NO
End Date:
Oct/UNK
/2019Transcription
Error
Oct-15-2020 13:15:03
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Hysterectomy
due to fibroid
Start Date: Oct/UNK/2019
Ongoing: NO
End Date:
Oct/UNK/2
019Transcription
Error
Oct-14-2020 17:04:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Hysterectom
y
Start Date: Oct/UNK/2
019Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999538
Page 116 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Ongoing: NO
End Date:
Oct/UNK
/2019
1.a Line/MH Number:
Date Location User Value Reason
Oct-14-2020 17:04:37
(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 ValueReason
Oct-15-2020
23:40:00
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
2: Clo
sedDiscrepancy has
been closed.
Oct-15-2020
17:03:21
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Hayley Wyper Query
1: Clo
sedResponse satisfies
query
Oct-15-2020
17:00:31
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dTranscription Error
Oct-15-2020
17:00:31
(UTC-03:00)
City ofACV0PFEINFP6000  Data
Entry
:
HysteTranscription Error
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999539
Page 117 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos
Airesrecto
my
Oct-15-2020
16:45:12
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
2: Op
enedMultiple concepts
in the term
HYSTERECTOMY
DUE TO
FIBROID. Split the
term into
HYSTERECTOMY
and UTERINE
FIBROID and
report as separate
entries. Thank you.
Oct-15-2020
13:15:03
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Oct-15-2020
13:15:03
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Data
Entry
:
Hyste
recto
my du
e to fi
broidTranscription Error
Oct-15-2020
10:38:11
(UTC-03:00)
City of
Buenos
AiresACV0PFEINFP6000  Hayley Wyper Query
1: Op
enedCLINQUERY:
Please review if
there is any medical
condition related to
this procedure to be
added to the MH
listing as a separate
entry
Oct-14-2020
17:04:37
(UTC-03:00)ACV0PFEINFP6000  Data
Entry
:Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999540
Page 118 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
City of
Buenos
AiresHyste
recto
my
1.a Start Date:
Date Location User Value Reason
Oct-14-2020 17:04:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-14-2020 17:04:37
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/UNK/2019Initial Entry
1.b
Date Location User Value Reason
Oct-14-2020 17:06:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Allergy Acetyl
salicylic acid
Start Date: UNK/UNK/198
4
Ongoing: YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999541
Page 119 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-14-2020 17:06:06
(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-14-2020 17:06:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Allergy Acetyl salicylic acidInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-14-2020 17:06:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-14-2020 17:06:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-14-2020 17:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Dipyrone al
lergy
Start Date: UNK/UNK/
1984Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999542
Page 120 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Oct-14-2020 17:06:38
(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-14-2020 17:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dipyrone allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-14-2020 17:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-14-2020 17:06:38
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-14-2020 17:07:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999543
Page 121 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Medical History
Term:Sulfa allerg
y
Start Date: UNK/UNK/
1984
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Oct-14-2020 17:07:12
(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-14-2020 17:07:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sulfa allergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-14-2020 17:07:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-14-2020 17:07:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999544
Page 122 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-14-2020 17:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Non-steroidal anti
-inflammatory all
ergy
Start Date
:UNK/UNK/1984
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Oct-14-2020 17:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-14-2020 17:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Non-steroidal anti-inflammat
ory allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-14-2020 17:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-14-2020 17:07:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999545
Page 123 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.f
Date Location User Value Reason
Oct-14-2020 17:08:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Psoriasis
Start Date: UNK/UNK/
1985
Ongoing: YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999546
Page 124 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.f Line/MH Number:
Date Location User Value Reason
Oct-14-2020 17:08:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 16:45:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Oct-15-2020 13:15:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 1: Answered Denies use of
immunosuppressive
medication
Oct-15-2020 10:38:55
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Please clarify if any
systemic
immunosuppressive
therapy has been
given for psoriasis
Oct-14-2020 17:08:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PsoriasisInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-14-2020 17:08:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1985Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999547
Page 125 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-14-2020 17:08:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-15-2020 17:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histo
ry Term:Uterine fibroi
d
Start Date: UNK/UNK/2
019
Ongoing: NO
End Date:
UNK/UN
K/2019Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999548
Page 126 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.g Line/MH Number:
Date Location User Value Reason
Oct-15-2020 17:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 17:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Uterine fibroidInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-15-2020 17:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-15-2020 17:01:06
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.h
Date Location User Value Reason
Nov-04-2020 13:03:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:Allergic rhi
nitisInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999549
Page 127 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Start Date: UNK/UNK/
1984
Ongoing: YES
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999550
Page 128 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Nov-04-2020 13:03:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 13:03:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Allergic rhinitisInitial Entry
1.h Start Date:
Date Location User Value Reason
Nov-04-2020 13:03:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.h Ongoing:
Date Location User Value Reason
Nov-04-2020 13:03:27
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Nov-04-2020
13:06:32 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
Line/MH
Number:9Transcription
Error
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999551
Page 129 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Medical Hi
story Term
:Prosthesis inser
tion in left arm
Start Date: UNK/UNK/201
6
Ongoing: NO
End Date:
UNK/UNK/
2016
Nov-04-2020
13:04:02 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Histo
ry Term:Left arm pr
osthesis
Start Date: UNK/UNK/
2016
Ongoing: YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999552
Page 130 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.i Line/MH Number:
Date Location User Value Reason
Nov-04-2020 13:04:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-04-2020 13:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Prosthesis insertion in left ar
mTranscription
Error
Nov-04-2020 13:04:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Left arm prosthesisInitial Entry
1.i Start Date:
Date Location User Value Reason
Nov-04-2020 13:04:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.i Ongoing:
Date Location User Value Reason
Nov-04-2020 13:06:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Transcription
Error
Nov-04-2020 13:04:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999553
Page 131 of 212
***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: 12412190 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-14-2020 17:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999554
Page 132 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
90.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999555
Page 133 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.3Initial Entry
7.a
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 36.7
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.7Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999556
Page 134 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
7.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 17:09:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999557
Page 135 of 212
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999558
Page 136 of 212
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX1
13
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-14-2020 17:09:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999559
Page 137 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-14-2020 17:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-14-2020 17:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
107634Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999560
Page 138 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 08:58:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 08:58:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 08:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 08:58:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 08:58:30
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999561
Page 139 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-15-2020 08:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRD429Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 08:58:39
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRD429Initial Entry
5.b
Date Location User Value Reason
Oct-15-2020 08:58:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BMM6SFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 08:58:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BMM6SFInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 08:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BMM6SGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 08:58:58
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BMM6SGInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999562
Page 140 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 14:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 14:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 14:11:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 14:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 14:11:07
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999563
Page 141 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-15-2020 14:11:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BRD41TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 14:11:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BRD41TInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999564
Page 142 of 212
***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: 12412190 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-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/14/2020 15:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999565
Page 143 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Oct-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 17:11:05
(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-14-2020 17:11:05
(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-14-2020 17:11:05
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999566
Page 144 of 212
***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: 12412190 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-14-2020 17:11:15
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999567
Page 145 of 212
***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: 12412190 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-04-2020 12:48:41
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999568
Page 146 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-04-2020 12:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2.a
Date Location User Value Reason
Nov-04-2020 12:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 36.6
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-04-2020 12:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-04-2020 12:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999569
Page 147 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-04-2020 12:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-04-2020 12:48:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999570
Page 148 of 212
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999571
Page 149 of 212
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX1
13
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Not Done:
Date Location User Value Reason
Nov-04-2020 12:49:17
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999572
Page 150 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 11:38:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 11:38:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 11:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 11:38:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-04-2020 11:38:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999573
Page 151 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-04-2020 11:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR79J0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-04-2020 11:38:19
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR79J0Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999574
Page 152 of 212
***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: 12412190 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-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/4/2020 12:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999575
Page 153 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Nov-04-2020 12:50:10
(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-04-2020 12:50:10
(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-04-2020 12:50:10
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999576
Page 154 of 212
***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: 12412190 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-03-2020
10:30:31
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/3/2020Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999577
Page 155 of 212
***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: 12412190 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 08:28:53
(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 08:28:53
(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 08:29:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-04-2020 08:28:53
(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 08:28:53
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999578
Page 156 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-04-2020 08:29:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR7C8HInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020 08:29:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR7C8HInitial Entry
5.b
Date Location User Value Reason
Dec-04-2020 08:29:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2KBSInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020 08:29:11
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2KBSInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020 08:29:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2KBTInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-04-2020 08:29:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2KBTInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999579
Page 157 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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-01-2020
07:29:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Closed entered
Nov-30-2020
10:08:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Answered Date of visit this
corridor,
21-Nov-2020
Nov-30-2020
08:28:16
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Query 3: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen form' at
this visit. Thank
you.
Nov-25-2020
10:03:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-25-2020
10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-25-2020
10:01:18
(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.
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0999580
Page 158 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-25-2020
10:01:18
(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-25-2020
10:01:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/24/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-25-2020 10:01:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999581
Page 159 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/24/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/22/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-07-2020 15:41:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Res
olved:
Nov/27/2020New Information
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999582
Page 160 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCR
EASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999583
Page 161 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-25-2020 10:02:04
(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-25-2020 10:02:04
(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-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999584
Page 162 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.d Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999585
Page 163 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.f
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF T
ASTE OR SMEL
L
Sympto
m Presen
t:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999586
Page 164 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.g Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(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-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999587
Page 165 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-25-2020 10:02:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-25-2020 10:02:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:Headach
eInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-25-2020 10:02:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
5.b
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999588
Page 166 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-25-2020 10:03:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other: FatigueInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-25-2020 10:03:12
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
5.c
Date Location User Value Reason
Dec-07-2020 15:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms - Other: NauseaInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-07-2020 15:41:08
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999589
Page 167 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-30-2020 15:40:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999590
Page 168 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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-30-2020
15:40:24 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/25/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-30-2020
15:40:24 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-30-2020
15:40:24 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-30-2020 15:40:24
(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-30-2020 15:40:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC
TESTInitial Entry
6. Trade Name:
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999591
Page 169 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-30-2020
15:40:24 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
ROCHE MOLECULAR S
YSTEMS COBAS SARS-C
OV-2Initial Entry
7. Test Result:
Date Location User Value Reason
Nov-30-2020
15:40:24 (UTC-03:00)
City of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999592
Page 170 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020 10:03:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020 10:03:46
(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-25-2020 10:03:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-25-2020 10:03:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-25-2020 10:03:46
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/24/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999593
Page 171 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Nov-25-2020 10:03:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: RR03345Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-25-2020 10:03:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RR03345Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999594
Page 172 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020 10:04:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020 10:04:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-25-2020 10:04:18
(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-25-2020 10:04:18
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Subject used self swabInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999595
Page 173 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999596
Page 174 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-25-2020 10:04:36
(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-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999597
Page 175 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-25-2020 10:04:36
(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-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-25-2020 10:04:36
(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
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999598
Page 176 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-25-2020 10:04:36
(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-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999599
Page 177 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Nov-25-2020 10:04:36
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999600
Page 178 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/24/2020Form: 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: 12412190 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-25-2020 10:04:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILL
NESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-25-2020 10:04:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-25-2020 10:04:49
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999601
Page 179 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/22/2020Form: 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: 12412190 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-22-2020 11:08:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/22/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-22-2020 11:08:50
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999602
Page 180 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/22/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-22-2020 13:59:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-22-2020 13:59:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-22-2020 13:59:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-22-2020 13:59:32
(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-22-2020 13:59:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999603
Page 181 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/22/2020Form: 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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-22-2020 13:59:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR796MInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-22-2020 13:59:42
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BR796MInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 13:59:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2JTHInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-22-2020 13:59:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2JTHInitial Entry
5.c
Date Location User Value Reason
Dec-22-2020 14:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2JTJInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-22-2020 14:00:02
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
BS2JTJInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999604
Page 182 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999605
Page 183 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999606
Page 184 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-03-2020 10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999607
Page 185 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-03-2020 10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999608
Page 186 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-03-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999609
Page 187 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Date Location User Value Reason
Dec-03-2020 10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999610
Page 188 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Left armpit lymph node enlar
gementInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/16/2020 UNK:UNKInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999611
Page 189 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020 12:51:59
(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-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 12:51:59 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999612
Page 190 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresNOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 12:51:59
(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-04-2020 12:51:59
(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-04-2020 12:51:59
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999613
Page 191 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 13:08:47
(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
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Pain in prosthesis in the left h
andInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/30/2020 UNK:UNKInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0999614
Page 192 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020 13:08:47
(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-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 13:08:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999615
Page 193 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos AiresNOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 13:08:47
(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-04-2020 13:08:47
(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-04-2020 13:08:47
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999616
Page 194 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-03-2020 10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-03-2020 10:34:54
(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
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Pain in prosthesis in the left
handInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-03-2020
10:34:54
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999617
Page 195 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
Nov/7/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-03-2020
10:34:54
(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
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-03-2020
10:34:54
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999618
Page 196 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-03-2020
10:34:54
(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
Dec-03-2020
10:34:54
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-03-2020
10:34:54ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999619
Page 197 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos Aires
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999620
Page 198 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-03-2020 10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-03-2020 10:37:04
(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
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-03-2020
10:37:04
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999621
Page 199 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
Nov/6/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-03-2020
10:37:04
(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
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-03-2020
10:37:04
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999622
Page 200 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-03-2020
10:37:04
(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
Dec-03-2020
10:37:04
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-03-2020
10:37:04ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999623
Page 201 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos Aires
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999624
Page 202 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-03-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-03-2020 10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
chillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999625
Page 203 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
Nov/6/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999626
Page 204 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-03-2020
10:38:21
(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
Dec-03-2020
10:38:21
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-03-2020
10:38:21ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999627
Page 205 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos Aires
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999628
Page 206 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Category:
Date Location User Value Reason
Dec-03-2020 10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-03-2020 10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999629
Page 207 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
Nov/6/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-03-2020
10:39:00
(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
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City ofACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999630
Page 208 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Buenos Aires
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-03-2020
10:39:00
(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
Dec-03-2020
10:39:00
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-03-2020
10:39:00ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (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-2021-5683-0999631
Page 209 of 212
***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
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of
Buenos Aires
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999632
Page 210 of 212
***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: 12412190 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-03-2020
10:31:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-03-2020 10:31:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-03-2020
10:31:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0999633
Page 211 of 212
***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: 12412190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-03-2020 10:31:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-14-2020 17:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-14-2020 17:03:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-03-2020 10:31:32
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/3/2020Initial Entry
Oct-14-2020 17:10:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
Oct-14-2020 17:03:34
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/14/2020Initial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0999634
Page 212 of 212
***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: 12412190 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 09:47:23
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000  Edson
MoreiraData Entry:
Click Here to EnableInitial Entry
090177e196ae3f47\Final\Final On: 01-Apr-2021 05:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0999635