Document text
Page 1 of 263
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option
is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991793
Page 2 of 263
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991794
Page 3 of 263
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Demography
1.Subject ID [12411067]
2.Birth Date: 1942
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991795
Page 4 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991796
Page 5 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85
years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent upon study
stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits, vaccination plan,
laboratory tests, lifestyle considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical examination, and
clinical judgment of the investigator to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance with the
requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active suicidal
ideation/behavior/lab abnormality that may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991797
Page 6 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction
(eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991798
Page 7 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or systemic
corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to study
entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing lipid
nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the study, site
staff otherwise supervised by the investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991799
Page 8 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991800
Page 9 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Systemic arterial hypertension]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Menopause]
Start Date: UNK/UNK/1995
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystectomy]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991801
Page 10 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [71.0]
3.Unit: kg
4.Height: [160.0]
5.Unit: cm
6.Body Mass Index: [27.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991802
Page 11 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991803
Page 12 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [226966]
3.Randomization Group: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991804
Page 13 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5SV8]
5.bSample ID [BP5SV9]
5.cSample ID [BP5SVB]
5.dSample ID [BLCSMR]
5.eSample ID [BLCSMS]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991805
Page 14 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5SSP]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991806
Page 15 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 16:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991807
Page 16 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991808
Page 17 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991809
Page 18 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991810
Page 19 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991811
Page 20 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991812
Page 21 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/2/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991813
Page 22 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BPT171]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991814
Page 23 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 11:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991815
Page 24 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991816
Page 25 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject Diary
was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991817
Page 26 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary was
completed?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991818
Page 27 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BPVY5Z]
5.bSample ID [BRXGC0]
5.cSample ID [BRXGC1]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991819
Page 28 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991820
Page 29 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/17/2020
2.Date of First Symptom Started: Dec/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/9/2021
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
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? YES
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [Abdominal pain]
5.bSymptoms - Other Text: [Nausea]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991821
Page 30 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Col
lectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/18/202
0 SWABBED MA
TERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991822
Page 31 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/18/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ROCHE MOLECULAR SYSTEMS COBAS SARS-COV-2
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991823
Page 32 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [RW92392]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991824
Page 33 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Subject used self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991825
Page 34 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [Medical home visit]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991826
Page 35 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991827
Page 36 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991828
Page 37 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Inflammatory colitis]
Date of Diagnosis:
Jan/29/2021
3.Toxicity Grade: 2
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991829
Page 38 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991830
Page 39 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991831
Page 40 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for Lab T
estVendor Na
meCollection Dat
e:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Identif
ierTest
:Result
:Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991832
Page 41 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991833
Page 42 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category for Lab
TestVendor Name (DERI
VED)Collection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991834
Page 43 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991835
Page 44 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991836
Page 45 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991837
Page 46 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991838
Page 47 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991839
Page 48 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991840
Page 49 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991841
Page 50 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991842
Page 51 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991843
Page 52 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991844
Page 53 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991845
Page 54 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/29/2021Form: 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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991846
Page 55 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/29/2021Form: 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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR6GX4]
5.bSample ID [BSD7G2]
5.cSample ID [BSD7G3]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991847
Page 56 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991848
Page 57 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Unplanned Assessments
1.Assessments
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991849
Page 58 of 263
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991850
Page 59 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991851
Page 60 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991852
Page 61 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991853
Page 62 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Urinary tract infection Dec/16/2020 UNK:
UNK NO
End Date Time:
Dec/22/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Mass in sigmoid Feb/8/2021 UNK:U
NK NO
End Date Time:
Feb/9/2021 UNK:UNK
Repeating
Pages
3.ADVERSE EVE
NT 3 Inflammatory colitis Dec/16/2020 UNK:
UNK YES Repeating
Pages
4.ADVERSE EVE
NT 4 Dipyrone allergy Jan/30/2021 UNK:U
NK NO
End Date Time:
Jan/30/2021 UNK:UNK
Repeating
Pages
5.ADVERSE EVE
NT 5 Chronic pangastritis Mar/2/2021 UNK:U
NK YES Repeating
Pages
6.ADVERSE EVE
NT 6 Diverticular disease of the
colon Dec/16/2020 UNK:
UNK YES Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991854
Page 63 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Urinary tract infection]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/22/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bacterial infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991855
Page 64 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991856
Page 65 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mass in sigmoid]
4.Start Date Time: Feb/8/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/9/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Diverticular disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991857
Page 66 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021144105]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991858
Page 67 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Inflammatory colitis]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Abnominal pain]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991859
Page 68 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991860
Page 69 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dipyrone allergy]
4.Start Date Time: Jan/30/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/30/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Allergy]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991861
Page 70 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991862
Page 71 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chronic pangastritis]
4.Start Date Time: Mar/2/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Helicobacter pylori]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991863
Page 72 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991864
Page 73 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diverticular disease of the colon]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991865
Page 74 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
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[2021144105]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991866
Page 75 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991867
Page 76 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991868
Page 77 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991869
Page 78 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991870
Page 79 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
1. Repeating
Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991871
Page 80 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991872
Page 81 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991873
Page 82 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991874
Page 83 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991875
Page 84 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991876
Page 85 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991877
Page 86 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991878
Page 87 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991879
Page 88 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991880
Page 89 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991881
Page 90 of 263
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991882
Page 91 of 263
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991883
Page 92 of 263
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991884
Page 93 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/21/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991885
Page 94 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991886
Page 95 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991887
Page 96 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991888
Page 97 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/29/2021
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991889
Page 98 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991890
Page 99 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991891
Page 100 of 263
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/24/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991892
Page 101 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
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 [BRKFKW]
5.bSample ID [BS2YBC]
5.cSample ID [BS2YBD]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991893
Page 102 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
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 [BRKFNJ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991894
Page 103 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/24/2021 11:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991895
Page 104 of 263
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991896
Page 105 of 263
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991897
Page 106 of 263
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991898
Page 107 of 263
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991899
Page 108 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991900
Page 109 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991901
Page 110 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991902
Page 111 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991903
Page 112 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991904
Page 113 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991905
Page 114 of 263
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991906
Page 115 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991907
Page 116 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991908
Page 117 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-12-2021 16:40:44 (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.
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0991909
Page 118 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aAug-12-2020 17:44:04 (UTC-03:00) City of Buenos
AiresSubject has no potential to become pregnant
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991910
Page 119 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aAug-12-2020 17:44:04 (UTC-03:00) City of Buenos
AiresSubject has no potential to become pregnant
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991911
Page 120 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
6.aAug-12-2020 17:44:04 (UTC-03:00) City of Buenos
AiresSubject has no potential to become pregnant
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0991912
Page 121 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
ItemDate User Comment
FormFeb-24-2021 16:06:35 (UTC-03:00) City of Buenos
AiresNot Applicable
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0991913
Page 122 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-12-2021 16:40:44 (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-09-2021 08:22:10 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-08-2021 15:42:38 (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-04-2021 14:48:09 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-01-2021 09:55:28 (UTC-03:00) City of Buenos
AiresBOOK Signed
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0991914
Page 123 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-24-2021 16:05:43 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-24-2021 12:01:17 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-17-2021 12:36:17 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-15-2021 16:45:36 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-12-2021 10:49:11 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0991915
Page 124 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Affidavit:
N/A
Approved Feb-12-2021 10:40:55 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations, tests,
evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-10-2021 15:16:37 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-04-2021 16:22:29 (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 Jan-29-2021 15:20:12 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Jan-21-2021 17:11:09 (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.
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0991916
Page 125 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
N/A Nov-27-2020 12:59:24 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Oct-13-2020 19:59:34 (UTC-03:00) City of Buenos
AiresBOOK Signed
Affidavit:
By my dated signature below, I, EdsonMoreira, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-05-2020 08:24:21 (UTC-03:00) City of Buenos
AiresEdit - All
signatures
invalidated
Affidavit:
N/A
Edson Moreira Approved Sep-16-2020 18:31:53 (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.
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0991917
Page 126 of 263
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020 17:38:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-12-2020 17:38:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991918
Page 127 of 263
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 17:39:11
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991919
Page 128 of 263
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020 17:38:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12411067Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 17:38:46
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1942Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020 17:39:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 17:39:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020 17:39:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991920
Page 129 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020 17:39:38
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991921
Page 130 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants bet
ween the ages of 18 and 55 yea
rs, inclusive, 65 and 85 years, i
nclusive, or 18 and 85 years, in
clusive, at randomization (depe
ndent upon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Male or female participants between the
ages of 18 and 55 years, inclusive, 65 an
d 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent u
pon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991922
Page 131 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusio
n Num
ber:2
Criterio
n Descr
iption:Participants who are willing an
d able to comply with all sche
duled visits, vaccination plan, l
aboratory tests, lifestyle consid
erations, and other study proce
dures
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN02A00Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991923
Page 132 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.b Inclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Participants who are willing and able to
comply with all scheduled visits, vaccina
tion plan, laboratory tests, lifestyle consi
derations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusio
n Num
ber:3
Criteri
on Desc
ription:Healthy participants who are d
etermined by medical history,
physical examination, and clini
cal judgment of the investigato
r to be eligible for inclusion in
the study
Criteri
on met
?:YESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991924
Page 133 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on ID: (
For Pfi
zer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Healthy participants who are determined
by medical history, physical examination
, and clinical judgment of the investigato
r to be eligible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Inclusio
n Numb
er:4
Criterio
n Descr
iption:Capable of giving personal sig
ned informed consent, which i
ncludes compliance with the r
equirements and restrictions li
sted in the ICD and in this prot
ocolInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991925
Page 134 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Capable of giving personal signed infor
med consent, which includes compliance
with the requirements and restrictions lis
ted in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:1Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991926
Page 135 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on Desc
ription:Other medical or psychiatric c
ondition incl. recent (within pa
st year) or active suicidal ideati
on/behavior/lab abnormality th
at may increase the risk of stud
y participation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condition in
cl. recent (within past year) or active suic
idal ideation/behavior/lab abnormality th
at may increase the risk of study particip
ationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991927
Page 136 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with huma
n immunodeficiency virus (
HIV), hepatitis C virus (HC
V), or hepatitis B virus (HB
V)
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Known infection with human immunode
ficiency virus (HIV), hepatitis C virus (H
CV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of BuenosACV0PFEINFP6000 Data Entry:
Exclusi 3Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991928
Page 137 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aires on Num
ber:
Criterio
n Descri
ption:History of severe adverse react
ion associated with a vaccine a
nd/or severe allergic reaction (
eg, anaphylaxis) to any compo
nent of the study intervention(
s)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
History of severe adverse reaction associ
ated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any compon
ent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991929
Page 138 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:4
Criterion Desc
ription:Receipt of medications
intended to prevent C
OVID-19
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Receipt of medications intended to preve
nt COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:8Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991930
Page 139 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterio
n Descri
ption:Immunocompromised individ
uals with known or suspected
immunodeficiency, as determi
ned by history and/or laborato
ry/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Immunocompromised individuals with k
nown or suspected immunodeficiency, as
determined by history and/or laboratory/
physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Num10Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991931
Page 140 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
ber:
Criterio
n Descri
ption:Bleeding diathesis or conditio
n associated with prolonged bl
eeding that would, in the opini
on of the investigator, contrain
dicate intramuscular injection
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition associate
d with prolonged bleeding that would, in
the opinion of the investigator, contraind
icate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of BuenosACV0PFEINFP6000 Data Entry:
Exclusion Numb 11Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991932
Page 141 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aires er:
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (Fo
r Pfizer use only)
:EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfeedin
gInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:12
Criterion Descr
iption:Previous vaccination
with any coronavirus
vaccine
Criterion met?: NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991933
Page 142 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criterion ID: (
For Pfizer use o
nly):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Previous vaccination with any coronavir
us vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, such
as cytotoxic agents or syste
mic corticosteroids
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX13A01Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991934
Page 143 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.i Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppressiv
e therapy, such as cytotoxic agents or sys
temic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:15
Criterio
n Descri
ption:Receipt of blood/plasma prod
ucts or immunoglobulin, from
60 days before study intervent
ion administration or planned
receipt throughout the study
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991935
Page 144 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.j Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stud
y intervention administration or planned
receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991936
Page 145 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
2.k
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:16
Criterio
n Descri
ption:Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study par
ticipation
Criterio
n met?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX15A01Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991937
Page 146 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.k Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Participation in other studies involving s
tudy intervention within 28 days prior to
study entry and/or during study participa
tionInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in ot
her studies involving study
intervention containing lipi
d nanoparticles
Criterion
met?:NO
Criterion I
D: (For Pfi
zer use onl
y):EX16A01Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991938
Page 147 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.l Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Previous participation in other studies in
volving study intervention containing lip
id nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfizer
employees directly involved in
the conduct of the study, site st
aff otherwise supervised by the
investigator, and their respecti
ve family members
Criteri
on met
?:NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991939
Page 148 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Criteri
on ID:
(For Pf
izer us
e only):EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer employee
s directly involved in the conduct of the
study, site staff otherwise supervised by
the investigator, and their respective fam
ily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 17:40:12
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991940
Page 149 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 17:40:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 17:40:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 17:40:23
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991941
Page 150 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 17:41:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Systemic arterial hyp
ertension
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020 17:41:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 17:41:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Systemic arterial hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020 17:41:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020 17:41:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-12-2020 17:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991942
Page 151 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Medical History Term
:Hypothyroidism
Start Date: UNK/UNK/199
5
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020 17:42:10
(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
Aug-12-2020 17:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020 17:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-12-2020 17:42:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-02-2020 13:20:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:Menopause
Start Date: UNK/UNK/199
5
Ongoing: YESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991943
Page 152 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.c Line/MH Number:
Date Location User Value Reason
Sep-02-2020 13:20:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 13:20:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
MenopauseInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-02-2020 13:20:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-02-2020 13:20:20
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Nov-27-2020 12:59:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Cholecystectomy
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/19
90Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991944
Page 153 of 263
***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: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
1.d Line/MH Number:
Date Location User Value Reason
Nov-27-2020 12:59:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-27-2020 12:59:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CholecystectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-27-2020 12:59:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-27-2020 12:59:24
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991945
Page 154 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
71.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
160.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.7Initial Entry
7.a
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991946
Page 155 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.0
Temperature Unit: C
Temperature Location
::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 03:01:45
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-12-2020 17:44:24
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Query 1: Answered Original value is
correct
Aug-12-2020 17:42:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 36 C is
outside of Normal
Range 36.1 - 37.5 C.
Aug-12-2020 17:42:40
(UTC-03:00) City of
Buenos AiresACV0PFEINFP6000 Data Entry:
36.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020 17:42:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991947
Page 156 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991948
Page 157 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a Sponsor ID:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-12-2020 17:42:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991949
Page 158 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 17:45:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 17:45:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
226966Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991950
Page 159 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 18:07:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 18:07:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 18:07:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 18:07:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-12-2020 18:07:14
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-17-2020 16:27:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-17-2020 08:38:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 1: Answered data updated
Aug-16-2020 01:56:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened Subject is listed to
have:3 serum samples,
which is less than the 5
expected. Please review
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991951
Page 160 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
and update Q4 as
appropriate, else clarify
5.a
Date Location User Value Reason
Aug-12-2020 18:07:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5SV8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 18:07:22
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BP5SV8Initial Entry
5.b
Date Location User Value Reason
Aug-12-2020 18:07:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5SV9Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020 18:07:31
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BP5SV9Initial Entry
5.c
Date Location User Value Reason
Aug-12-2020 18:07:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5SVBInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-12-2020 18:07:40
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BP5SVBInitial Entry
5.d
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0991952
Page 161 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-17-2020 08:38:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCSMRInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 08:38:59
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BLCSMRInitial Entry
5.e
Date Location User Value Reason
Aug-17-2020 08:39:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BLCSMSInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 08:39:07
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BLCSMSInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991953
Page 162 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 18:07:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 18:07:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 18:08:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 18:07:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-12-2020 18:07:54
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 18:08:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BP5SSPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 18:08:02
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BP5SSPInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0991954
Page 163 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Aug/12/2020 16:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991955
Page 164 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-12-2020 17:46:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991956
Page 165 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020 17:46:09
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991957
Page 166 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 13:05:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991958
Page 167 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Sub
ject Diary was completed?:NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991959
Page 168 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991960
Page 169 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 13:05:49 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991961
Page 170 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of Buenos
AiresSymptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.f Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991962
Page 171 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991963
Page 172 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
S
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991964
Page 173 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 13:05:49
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991965
Page 174 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 13:07:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020 13:07:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Location
::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 13:07:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-02-2020 13:07:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020 13:07:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 13:07:27
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991966
Page 175 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991967
Page 176 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020 13:17:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991968
Page 177 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 14:46:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 14:46:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 14:47:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 14:46:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-02-2020 14:46:53
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 14:47:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPT171Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 14:47:03
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPT171Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0991969
Page 178 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sep/2/2020 11:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991970
Page 179 of 263
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-02-2020 13:17:37
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991971
Page 180 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 08:24:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991972
Page 181 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symptoms
present on the last day the Subjec
t Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic symptom
s present on the last day the Sub
ject Diary was completed?:NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991973
Page 182 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.b Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: CH
ILL
SInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991974
Page 183 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Were fever or systemic symptom
s present on the last day the Subj
ect Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-05-2020 08:25:08 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991975
Page 184 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
(UTC-03:00) City of Buenos
AiresSymptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.f Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSENE
D MUSCL
E PAIN
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991976
Page 185 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
2.h
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RED
NESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991977
Page 186 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
S
Were injection site reactions pre
sent on the last day the Subject
Diary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLIN
G
Were injection site reactions pr
esent on the last day the Subjec
t Diary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991978
Page 187 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED DATES
- eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: PAIN AT
INJECTI
ON SITE
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-05-2020 08:25:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0991979
Page 188 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-05-2020 09:24:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 09:24:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 09:24:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 09:24:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-05-2020 09:24:10
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 09:24:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BPVY5ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 09:24:21
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BPVY5ZInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991980
Page 189 of 263
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
5.b
Date Location User Value Reason
Oct-05-2020 09:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXGC0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-05-2020 09:24:41
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BRXGC0Initial Entry
5.c
Date Location User Value Reason
Oct-05-2020 09:24:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Sample ID: BRXGC1Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-05-2020 09:24:50
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
BRXGC1Initial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991981
Page 190 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-22-2020 02:24:25
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Dec-21-2020 09:37:28
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 3: Answered data updated
Dec-21-2020 08:39:30
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 3: Opened DM: Kindly review and
complete
‘Microbiology
Specimen form' at this
visit. Thank you.
Dec-18-2020 11:30:08
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-18-2020 11:28:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing. Please
review and update as
appropriate.
Dec-18-2020 11:28:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date of
Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please review
and update as
appropriate.
Dec-18-2020 11:28:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0991982
Page 191 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-18-2020 11:28:15
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
FDA-CBER-2021-5683-0991983
Page 192 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-01-2021 10:50:43
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-01-2021 09:02:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Mar-01-2021 09:02:39
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Feb/9/2021New Information
Feb-26-2021 18:22:18
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Query 1: Opened Clin: As subject was
recently vaccinated on
24Feb2021, please
clarify whether the
reported symptoms are
still ongoing. If
symptoms have ended,
please update
‘Symptoms Ongoing’
to ‘NO’ and add Date
of Last Symptom
Resolved on the CRF.
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991984
Page 193 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
4.a
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
COUGH
Symptom Pre
sent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991985
Page 194 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1241 Site Name: (1241) Hospital Irma Dulce
Subject No: 12411067 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 19:09
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED SH
ORTNESS OF BREATH
Symptom
Present:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Dec-18-2020 11:28:51
(UTC-03:00) City of Buenos
AiresACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAINInitial Entry
090177e196ae3f75\Final\Final On: 01-Apr-2021 05:16 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0991986
Page 195 of 263
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/17/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail Hist
…[truncated]