125742 S1 M5 CRF c4591001 1241 12412411

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
281
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000415
Page 2 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/20/2020
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000416
Page 3 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Demography
1.Subject ID [12412411]
2.Birth Date: 1987
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
AMERICAN INDIAN OR ALASKA NATIVE
WHITE
6.Racial Designation:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000417
Page 4 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000418
Page 5 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000419
Page 6 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000420
Page 7 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/1997
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Lactose intolerance]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000421
Page 8 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000422
Page 9 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Vital Signs
1.Date: Oct/20/2020
2.Weight: [74.5]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000423
Page 10 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/20/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000424
Page 11 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/20/2020
2.Randomization Number: [111122]
3.Randomization Group: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000425
Page 12 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR74FN]
5.bSample ID [BS5CCR]
5.cSample ID [BS5CCS]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000426
Page 13 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR74F8]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000427
Page 14 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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/20/2020 17:32
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000428
Page 15 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000429
Page 16 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000430
Page 17 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Vital Signs
1.Date: Nov/10/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000431
Page 18 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/10/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000432
Page 19 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BR5V60]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000433
Page 20 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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/10/2020 11:55
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000434
Page 21 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000435
Page 22 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
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 [BR792D]
5.bSample ID [BS2JJ3]
5.cSample ID [BS2JJ4]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000436
Page 23 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000437
Page 24 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/27/2021
2.Date of First Symptom
Started:Jan/22/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/28/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000438
Page 25 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
5.bSymptoms - Other Text: [Headache]
5.cSymptoms - Other Text: [Runny nose]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000439
Page 26 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Date of
Collecti
onSpecimen
TypeSpecimen C
ollection Lo
cationAssay Code and Descr
iptionDevice TypeForm Insta
nce
 1.Jan/28/
2021 SWABBE
D MATER
IAL NASOPHAR
YNX SEVERE ACUTE RES
P SYNDROME CORO
NAVIRUS 2 SARS-COV-2
DIAGNOSTI
C TEST Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000440
Page 27 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/28/2021
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: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: NEGATIVE
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000441
Page 28 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[Subject used site swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000442
Page 29 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRKC4V]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000443
Page 30 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000444
Page 31 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000445
Page 32 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000446
Page 33 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000447
Page 34 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000448
Page 35 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000449
Page 36 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000450
Page 37 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000451
Page 38 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000452
Page 39 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000453
Page 40 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000454
Page 41 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000455
Page 42 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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:[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000456
Page 43 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000457
Page 44 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000458
Page 45 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000459
Page 46 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000460
Page 47 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000461
Page 48 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000462
Page 49 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000463
Page 50 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000464
Page 51 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000465
Page 52 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCFKX]
5.bSample ID [BS2L74]
5.cSample ID [BS2L75]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000466
Page 53 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000467
Page 54 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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 [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000468
Page 55 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERS
E EVENT
 1  Maternal exposure
during pregnancy Feb/12/2021
UNK:UNK YES  Repeating
Pages
 2.ADVERS
E EVENT
 2  Injection site pain  Feb/8/2021 20
:00 NO
End Date Time:
Feb/10/2021 U
NK:UNK
 Repeating
Pages
 3.ADVERS
E EVENT
 3  Fever  Feb/8/2021 20
:00 NO
End Date Time:
Feb/10/2021 U
NK:UNK
 Repeating
Pages
 4.ADVERS
E EVENT
 4  Headache  Feb/8/2021 20
:00 NO
End Date Time:
Feb/10/2021 U
NK:UNK
 Repeating
Pages
 5.ADVERS
E EVENT
 5  Myalgia  Feb/8/2021 20
:00 NO
End Date Time:
Feb/10/2021 U
NK:UNK
 Repeating
Pages
 6.ADVERS
E EVENT6  Right breast fibroa
denoma Nov/UNK/20
20 UNK:UNYES  Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000469
Page 56 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
  K 
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000470
Page 57 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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)[Maternal exposure during pregnancy]
4.Start Date Time: Feb/12/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000471
Page 58 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[Pregnancy]
10.Latest Action Taken with
Study Treatment:DRUG WITHDRAWN
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000472
Page 59 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000473
Page 60 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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)[Injection site pain]
4.Start Date Time: Feb/8/2021 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000474
Page 61 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000475
Page 62 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000476
Page 63 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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)[Fever]
4.Start Date Time: Feb/8/2021 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000477
Page 64 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000478
Page 65 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000479
Page 66 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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)[Headache]
4.Start Date Time: Feb/8/2021 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000480
Page 67 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000481
Page 68 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000482
Page 69 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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)[Myalgia]
4.Start Date Time: Feb/8/2021 20:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000483
Page 70 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000484
Page 71 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000485
Page 72 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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)[Right breast fibroadenoma]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000486
Page 73 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000487
Page 74 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000488
Page 75 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000489
Page 76 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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[ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000490
Page 77 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000491
Page 78 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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: //
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000492
Page 79 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000493
Page 80 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000494
Page 81 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000495
Page 82 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000496
Page 83 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000497
Page 84 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000498
Page 85 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000499
Page 86 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Unplanned Assessments
1.Assessments
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000500
Page 87 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000501
Page 88 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000502
Page 89 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000503
Page 90 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
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?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000504
Page 91 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000505
Page 92 of 281
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000506
Page 93 of 281
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000507
Page 94 of 281
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000508
Page 95 of 281
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000509
Page 96 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000510
Page 97 of 281
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000511
Page 98 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000512
Page 99 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000513
Page 100 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000514
Page 101 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/8/2021
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000515
Page 102 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000516
Page 103 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/8/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000517
Page 104 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/8/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000518
Page 105 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6FJV]
5.bSample ID [BS2Y2M]
5.cSample ID [BS2Y2N]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000519
Page 106 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6FJ6]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000520
Page 107 of 281
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 17:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000521
Page 108 of 281
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000522
Page 109 of 281
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/8/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: POSITIVE
Not Done:
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000523
Page 110 of 281
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCFL8]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000524
Page 111 of 281
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was
ObservedNot Done Comments
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000525
Page 112 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?Not Done Comments
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000526
Page 113 of 281
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000527
Page 114 of 281
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000528
Page 115 of 281
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000529
Page 116 of 281
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000530
Page 117 of 281
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000531
Page 118 of 281
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000532
Page 119 of 281
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: PREGNANCY
4.Specify Status: [ ]
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000533
Page 120 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000534
Page 121 of 281
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000535
Page 122 of 281
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-11-2021 19:01:49 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000536
Page 123 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
FormOct-21-2020 08:42:14 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000537
Page 124 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
6Mar-08-2021 12:54:36 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000538
Page 125 of 281
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
FormFeb-08-2021 18:15:55 (UTC-03:00)
City of Buenos AiresNot Applicable
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000539
Page 126 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
FormMar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000540
Page 127 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
1Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000541
Page 128 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
2Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000542
Page 129 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
3Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000543
Page 130 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
4Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000544
Page 131 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
5Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000545
Page 132 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
6Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000546
Page 133 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
7Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000547
Page 134 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
8Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000548
Page 135 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
9Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000549
Page 136 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
10Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000550
Page 137 of 281
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
ItemDate User Comment
11Mar-08-2021 12:50:20 (UTC-03:00)
City of Buenos AiresSubject is pregnant
Not Done
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000551
Page 138 of 281
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Mar-11-2021 19:01:49 (UTC-03:00)
City of Buenos AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display
the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-08-2021 12:48:27 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Feb-12-2021 18:05:40 (UTC-03:00)
City of Buenos AiresBOOK Signed
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000552
Page 139 of 281
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Feb-08-2021 18:14:11 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Feb-02-2021 16:38:58 (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.
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000553
Page 140 of 281
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
 N/A Jan-27-2021 18:38:59 (UTC-03:00)
City of Buenos AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson
Moreira Approved Jan-22-2021 11:07:51 (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.
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000554
Page 141 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-21-2020
08:41:30
(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-21-2020
08:41:30
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000555
Page 142 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-21-2020
08:41:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Con
sent Obtained
Oct/20/2020Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000556
Page 143 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-21-2020
08:41:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12412411Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-21-2020
08:41:18
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1987Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-21-2020
08:41:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-21-2020
08:41:58
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) ORInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000557
Page 144 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
of Buenos Aires OF SPANISH ORI
GIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-21-2020
08:41:58
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BLACK OR AFRI
CAN AMERICAN
AMERICAN INDI
AN OR ALASKA
NATIVE
WHITEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000558
Page 145 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020
08:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000559
Page 146 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-21-2020
08:42:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-21-2020
08:42:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-21-2020
08:42:35
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000560
Page 147 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1.a
Date Location User Value Reason
Oct-21-2020
08:43:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Allergic
rhinitis
Start Date: UNK/U
NK/199
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-21-2020
08:43:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-21-2020
08:43:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Allergic rhinitisInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000561
Page 148 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
1.a Start Date:
Date Location User Value Reason
Oct-21-2020
08:43:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/1997Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-21-2020
08:43:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-21-2020
08:44:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term
:Lactose i
ntoleranc
e
Start Date: UNK/UN
K/2012
Ongoing: YESInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000562
Page 149 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
1.b Line/MH Number:
Date Location User Value Reason
Oct-21-2020
08:44:19
(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-21-2020
08:44:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Lactose intoleranceInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-21-2020
08:44:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-21-2020
08:44:19
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000563
Page 150 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-21-2020
08:44:28
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
The subject is NOT
known to be HIV P
OSITIVEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000564
Page 151 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
74.5Initial Entry
3. Unit:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-21-2020
08:44:57ACV0PFEINFP6000  Data Entry:
162.0Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000565
Page 152 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
(UTC-03:00) City
of Buenos Aires
5. Unit:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.4Initial Entry
7.a
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.9
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000566
Page 153 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
7.a Record Identifier:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-21-2020
08:44:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000567
Page 154 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-21-2020
08:45:09ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000568
Page 155 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
(UTC-03:00) City
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-21-2020
08:45:09ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000569
Page 156 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
(UTC-03:00) City
of Buenos Aires
6.a Test:
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-21-2020
08:45:09
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000570
Page 157 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-21-2020
08:45:15
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-21-2020
08:45:27
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
111122Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000571
Page 158 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
10:21:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
10:21:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
10:21:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
10:21:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000572
Page 159 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
and correct as
appropriate.
Oct-21-2020
10:21:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
10:21:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR74F
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
10:21:34
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR74FNInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020
10:21:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS5CC
RInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000573
Page 160 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
5.b Sample ID
Date Location User Value Reason
Oct-21-2020
10:21:48
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS5CCRInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020
10:21:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BS5CC
SInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020
10:21:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS5CCSInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000574
Page 161 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020
11:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-21-2020
11:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020
11:26:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-21-2020
11:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000575
Page 162 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
and correct as
appropriate.
Oct-21-2020
11:26:32
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020
11:26:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BR74F8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020
11:26:39
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR74F8Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000576
Page 163 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Oct/20/2020 17:32Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000577
Page 164 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-21-2020
08:45:56
(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-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000578
Page 165 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-21-2020
08:45:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000579
Page 166 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-21-2020
08:46:02
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTE
D FOR THIS SUBJ
ECTInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000580
Page 167 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020
12:31:33
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/10/2020Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000581
Page 168 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date:
Date Location User Value Reason
Nov-10-2020
12:31:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/10/2020Initial Entry
2.a
Date Location User Value Reason
Nov-10-2020
12:31:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:36.6
Temperat
ure Unit:C
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-10-2020
12:31:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000582
Page 169 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
2.a Temperature:
Date Location User Value Reason
Nov-10-2020
12:31:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-10-2020
12:31:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-10-2020
12:31:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000583
Page 170 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Nov/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-10-2020
12:32:03ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000584
Page 171 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
(UTC-03:00) City
of Buenos Aires
5. Specimen Type:
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-10-2020
12:32:03ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000585
Page 172 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
(UTC-03:00) City
of Buenos Aires
6.a Test:
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Choriogonadotropi
n Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-10-2020
12:32:03
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000586
Page 173 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020
07:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020
07:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020
07:45:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-11-2020
07:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000587
Page 174 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
and correct as
appropriate.
Nov-11-2020
07:45:21
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-11-2020
07:45:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR5V6
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-11-2020
07:45:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR5V60Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000588
Page 175 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Nov/10/2020 11:55Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000589
Page 176 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
of Buenos Aires
5. Anatomical Location:
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-10-2020
12:32:29
(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-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000590
Page 177 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-10-2020
12:32:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000591
Page 178 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-11-2020
08:11:31
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000592
Page 179 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-11-2020
09:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-11-2020
09:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-11-2020
09:14:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-11-2020
09:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000593
Page 180 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
and correct as
appropriate.
Dec-11-2020
09:14:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
Dec-11-2020
09:14:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BR792
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-11-2020
09:14:55
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BR792DInitial Entry
5.b
Date Location User Value Reason
Dec-11-2020
09:15:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2JJ3Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000594
Page 181 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
5.b Sample ID
Date Location User Value Reason
Dec-11-2020
09:15:05
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS2JJ3Initial Entry
5.c
Date Location User Value Reason
Dec-11-2020
09:15:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2JJ4Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-11-2020
09:15:12
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS2JJ4Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000595
Page 182 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021
04:37:31
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Closed data updated
Mar-08-2021
12:47:58
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Answer
eddata updated
Mar-04-2021
08:53:26
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 4: Opened PDQ:
Convalescent
visit is missing
and 35+ days
(36) have
passed since
COVID Illness
Visit. If visit
occurred record
data as a
matching
CONVA visit;
if visit did not
occur attempt
to schedule
visit even if
OOW and
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000596
Page 183 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
obtain the
CONVA
sample else
clarify.
Feb-01-2021
18:37:51
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Feb-01-2021
11:42:37
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Answer
eddata updated
Jan-28-2021
11:59:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 3: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen form'
at this visit.
Thank you.
Jan-27-2021
18:41:10
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-27-2021
18:39:44
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000597
Page 184 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Jan-27-2021
18:38:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 2: Candida
teDate of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing. Please
review and
update as
appropriate.
Jan-27-2021
18:38:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teDate of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and
update as
appropriate.
Jan-27-2021
18:38:57
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-27-2021 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000598
Page 185 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
18:38:57
(UTC-03:00) City
of Buenos Aires(autocalc) COVID_A
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000599
Page 186 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-27-2021
18:39:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened All symptoms
are reported as
Not Present
and there is no
Other
Symptom
reported.
Please review
and update as
appropriate.
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000600
Page 187 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-08-2021
18:14:11
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
Date of Last Sympt
om Resolved:
Jan/28/2021New
Information
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000601
Page 188 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.a Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000602
Page 189 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.b Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Symp
tom
Prese
nt:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000603
Page 190 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.c Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SHORTNESS OF
BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000604
Page 191 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.d Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED
MUSCLE P
AIN
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000605
Page 192 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.e Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000606
Page 193 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.f Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR IN
CREASED S
ORE THRO
AT
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000607
Page 194 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.g Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000608
Page 195 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.h Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms: VOMIT
ING
Symptom
Present:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000609
Page 196 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
4.i Symptoms:
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-27-2021
18:39:44
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jan-27-2021
18:39:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Fatig
ueInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-27-2021
18:39:59
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000610
Page 197 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
5.b
Date Location User Value Reason
Jan-27-2021
18:40:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Heada
cheInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Jan-27-2021
18:40:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
5.c
Date Location User Value Reason
Jan-27-2021
18:40:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Symptoms -
Other:Runny
noseInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Jan-27-2021
18:40:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Runny noseInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000611
Page 198 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000612
Page 199 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SWABBED MATERI
ALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) CityACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RES
P SYNDROME COROInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000613
Page 200 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
of Buenos Aires NAVIRUS 2
5. Device Type:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGN
OSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
ABBOTT MOLECU
LAR REALTIME SA
RS-COV-2 ASSAYInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-01-2021
11:42:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000614
Page 201 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021
18:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021
18:41:01
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
18:41:01
(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
Jan-27-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000615
Page 202 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
18:41:01
(UTC-03:00) City
of Buenos AiresSubject used site swa
b
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1000616
Page 203 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021
18:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021
18:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021
18:41:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-27-2021
18:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000617
Page 204 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: 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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
and correct as
appropriate.
Jan-27-2021
18:41:10
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021
18:41:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID
:BRKC4
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-27-2021
18:41:20
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRKC4VInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000618
Page 205 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1.a
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:SPEC
IALI
ST
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000619
Page 206 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pr
actitioner:EMER
GENCY
ROOM
Occurrenc
e of Visits
or Contact
s:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
EMERGENCY ROO
MInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-27-2021
18:41:45ACV0PFEINFP6000  Data Entry:
Type of P PRIMARInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000620
Page 207 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
(UTC-03:00) City
of Buenos Airesractitione
r:Y CARE
PHYSICI
AN
Occurren
ce of Visit
s or Cont
acts:NO
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
PRIMARY CARE P
HYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Pra
ctitioner:URGE
NT C
AREInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000621
Page 208 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Occurrence
of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of P
ractitione
r:TELEPH
ONE CO
NSULTA
TION
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000622
Page 209 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
TELEPHONE CONS
ULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:OT
HE
R
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000623
Page 210 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-27-2021
18:41:45
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000624
Page 211 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/27/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-27-2021
18:41:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-
19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Jan-27-2021
18:41:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021
18:41:56
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000625
Page 212 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
12:48:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Mar/8/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-08-2021
12:48:26
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000626
Page 213 of 281
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021
13:52:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021
13:52:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021
13:52:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
13:52:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-1000627
Page 214 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
and correct as
appropriate.
Mar-08-2021
13:52:42
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021
13:52:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample I
D:BRCFK
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021
13:52:54
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BRCFKXInitial Entry
5.b
Date Location User Value Reason
Mar-08-2021
13:53:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2L74Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000628
Page 215 of 281
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Mar/08/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
5.b Sample ID
Date Location User Value Reason
Mar-08-2021
13:53:06
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS2L74Initial Entry
5.c
Date Location User Value Reason
Mar-08-2021
13:53:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Sample ID: BS2L75Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-08-2021
13:53:14
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
BS2L75Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000629
Page 216 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000630
Page 217 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000631
Page 218 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000632
Page 219 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000633
Page 220 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Mar-10-2021
09:00:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000634
Page 221 of 281
***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: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
Date Location User Value Reason
Mar-10-2021
09:02:29
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000 Form Created
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000635
Page 222 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021
10:36:59
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Closed Response
satisfies query
Mar-10-2021
09:02:56
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Answer
eddata updated
Mar-09-2021
17:18:41
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 2: Opened As per source
document,
subject also
reported myalgia
and
fibroadenoma at
V102. Please
verify and
update, if
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1000636
Page 223 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
applicable.
Mar-09-2021
17:17:03
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Closed Opened in error.
Mar-09-2021
17:15:05
(UTC-03:00)
City of Buenos
AiresACV0PFEINFP6000  Query 1: Opened Could you
please clarify the
reason why the
AEs
"Fibroadenoma"
and "Myalgia"
described on
V102 were not
reported? If
applicable,
please update
CRF. Thank
you!
Mar-08-2021
12:54:22
(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
Mar-08-2021
12:54:22
(UTC-03:00) CityACV0PFEINFP6000  Data Entry:
Maternal exposure du
ring pregnancyInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000637
Page 224 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
of Buenos Aires
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021
15:11:57
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/12/2021 UNK:
UNKTranscription
Error
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Feb/8/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
12:54:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000638
Page 225 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHERInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000639
Page 226 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
If Other, specify:
Pregnancy
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
DRUG WITHDRAW
NInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
12:54:22
(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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000640
Page 227 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Mar-09-2021
13:46:46
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Mar-08-2021
12:54:52
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Query 1: Answered Original value
is correct
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE
Maternal
exposure
during
pregnancy:
Response to
"What was the
outcome of
this adverse
event?" is
'Unknown' but
End
Date/Time is
provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000641
Page 228 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date Location User Value Reason
Mar-08-2021
12:54:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000642
Page 229 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
12:57:47
(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
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000643
Page 230 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
12:57:47
(UTC-03:00) City
of Buenos AiresFeb/8/2021 20:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
12:57:47
(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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000644
Page 231 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Mar-08-2021
12:57:47
(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
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000645
Page 232 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
12:57:47
(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
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
12:57:47
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000646
Page 233 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000647
Page 234 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
12:58:36
(UTC-03:00) City
of Buenos AiresFeb/8/2021 20:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
12:58:36
(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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000648
Page 235 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000649
Page 236 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
12:58:36
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000650
Page 237 of 281
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-08-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000651
Page 238 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
12:59:25
(UTC-03:00) City
of Buenos AiresFeb/8/2021 20:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
12:59:25
(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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000652
Page 239 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000653
Page 240 of 281
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
12:59:25
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000654
Page 241 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021
09:00:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021
09:00:22
(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
Mar-10-2021
09:00:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
MyalgiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1000655
Page 242 of 281
***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, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12412411 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:52
09:00:22
(UTC-03:00) City
of Buenos AiresFeb/8/2021 20:00
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021
09:00:22
(UTC-03:00) City
of Buenos AiresACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021
09:00:22
(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
090177e196ae3f3a\Final\Final On: 01-Apr-2021 05:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1000656
Page 243 of 281
***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, Verified
Site No: 12
…[truncated]
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