125742 S1 M5 CRF c4591001 1110 11101031

Document text

Page 1 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924296
Page 2 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/4/2020
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924297
Page 3 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Demography
1.Subject ID [11101031]
2.Birth Date: /1954
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924298
Page 4 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/4/2020
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924299
Page 5 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924300
Page 6 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924301
Page 7 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924302
Page 8 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924303
Page 9 of 199
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NEPHROLITHIASIS]
Start Date: Jan/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2005
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SLEEP DISTURBANCE]
Start Date: Jan/UNK/2019
Ongoing: YES
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924304
Page 10 of 199
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetes Mellitus Type 2]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924305
Page 11 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/4/2020
2.Weight: [95.25]
3.Unit: kg
4.Height: [169.0]
5.Unit: cm
6.Body Mass Index: [33.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924306
Page 12 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/4/2020
2.Randomization Number: [221835]
3.Randomization Group: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924307
Page 13 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3H0M]
5.bSample ID [BP3H0N]
5.cSample ID [BP3H0P]
5.dSample ID [BPLH8T]
5.eSample ID [BPLH8V]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924308
Page 14 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3H3V]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924309
Page 15 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/4/2020 12:37
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924310
Page 16 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924311
Page 17 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924312
Page 18 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924313
Page 19 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924314
Page 20 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: FOREHEAD
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924315
Page 21 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BPY0JS]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924316
Page 22 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/25/2020 10:51
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924317
Page 23 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924318
Page 24 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924319
Page 25 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924320
Page 26 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BPY09P]
5.bSample ID [BRVHMZ]
5.cSample ID [BRVHMX]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924321
Page 27 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924322
Page 28 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924323
Page 29 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924324
Page 30 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924325
Page 31 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924326
Page 32 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924327
Page 33 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924328
Page 34 of 199
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924329
Page 35 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924330
Page 36 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Unplanned Assessments
1.Assessments
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924331
Page 37 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924332
Page 38 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924333
Page 39 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924334
Page 40 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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 [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924335
Page 41 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Uncontrolled Diabetes Melli
tus Type 2 Nov/10/2020 UN
K:UNK NO
End Date Time:
Nov/13/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924336
Page 42 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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)[Uncontrolled Diabetes Mellitus Type 2]
4.Start Date Time: Nov/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/13/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
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:
[diabetes mellitus type 2 uncontrolled]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924337
Page 43 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020451042]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924338
Page 44 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924339
Page 45 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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[ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924340
Page 46 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924341
Page 47 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: //
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924342
Page 48 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924343
Page 49 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924344
Page 50 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924345
Page 51 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924346
Page 52 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924347
Page 53 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924348
Page 54 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924349
Page 55 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924350
Page 56 of 199
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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?
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924351
Page 57 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924352
Page 58 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924353
Page 59 of 199
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924354
Page 60 of 199
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924355
Page 61 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924356
Page 62 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924357
Page 63 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924358
Page 64 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924359
Page 65 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
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 [BNPZ7K]
5.bSample ID [BNPZ7L]
5.cSample ID [BN4ZBH]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924360
Page 66 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
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 [BN4Z8S]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924361
Page 67 of 199
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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: Jan/25/2021 09:27
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924362
Page 68 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/31/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924363
Page 69 of 199
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924364
Page 70 of 199
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924365
Page 71 of 199
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924366
Page 72 of 199
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
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 [BPZXDW]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924367
Page 73 of 199
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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/15/2021 09:34
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
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924368
Page 74 of 199
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924369
Page 75 of 199
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924370
Page 76 of 199
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924371
Page 77 of 199
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924372
Page 78 of 199
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924373
Page 79 of 199
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924374
Page 80 of 199
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924375
Page 81 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/23/2020
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924376
Page 82 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924377
Page 83 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jeffrey Rosen  Approved Mar-12-2021 11:27:17 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924378
Page 84 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
ItemDate User Comment
FormJan-25-2021 14:31:56 (UTC-05:00) Eastern Time
(US & Canada)n/a
Not Applicable
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924379
Page 85 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jeffrey Rosen  Approved Mar-12-2021 11:27:17 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-11-2021 07:38:11 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Mar-05-2021 16:14:01 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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 17:33:34 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Mar-01-2021 17:29:33 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924380
Page 86 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, JeffreyRosen, 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-25-2021 10:34:53 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Feb-18-2021 10:46:38 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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-15-2021 16:42:44 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Feb-03-2021 20:41:02 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924381
Page 87 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
 N/A Jan-25-2021 14:31:26 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Jan-21-2021 10:00:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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-04-2021 17:58:46 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Dec-10-2020 17:04:36 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-18-2020 07:40:45 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Nov-17-2020 16:45:46 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924382
Page 88 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-17-2020 14:46:40 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Nov-17-2020 08:35:30 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 10:29:23 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Oct-08-2020 17:14:09 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924383
Page 89 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
 N/A Sep-23-2020 17:43:52 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jeffrey Rosen  Approved Sep-10-2020 11:47:24 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JeffreyRosen, 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.
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924384
Page 90 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-04-2020 17:11:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-04-2020 17:11:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924385
Page 91 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020 17:11:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/4/2020Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0924386
Page 92 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020 17:11:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11101031Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-04-2020 17:11:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-04-2020 17:12:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-04-2020 17:12:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-04-2020 17:12:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924387
Page 93 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-04-2020 17:15:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924388
Page 94 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants
between the ages of 18 and
55 years, inclusive, 65 and 8
5 years, inclusive, or 18 and
85 years, inclusive, at rando
mization (dependent upon st
udy stage)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants between t
he ages of 18 and 55 years, inclusive,
65 and 85 years, inclusive, or 18 and
85 years, inclusive, at randomization
(dependent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924389
Page 95 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willing
and able to comply with all
scheduled visits, vaccinatio
n plan, laboratory tests, life
style considerations, and ot
her study procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN02A00Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924390
Page 96 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.b Inclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participants who are willing and able
to comply with all scheduled visits, v
accination plan, laboratory tests, lifes
tyle considerations, and other study p
roceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who ar
e determined by medical his
tory, physical examination,
and clinical judgment of the
investigator to be eligible fo
r inclusion in the studyInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924391
Page 97 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants who are determi
ned by medical history, physical exa
mination, and clinical judgment of th
e investigator to be eligible for inclus
ion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924392
Page 98 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving personal
signed informed consent, w
hich includes compliance w
ith the requirements and res
trictions listed in the ICD a
nd in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only):IN04A00
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0924393
Page 99 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Inclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signed inf
ormed consent, which includes compl
iance with the requirements and restri
ctions listed in the ICD and in this pr
otocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (withi
n past year) or active suicid
al ideation/behavior/lab abn
ormality that may increase t
he risk of study participatio
nInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924394
Page 100 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric conditio
n incl. recent (within past year) or act
ive suicidal ideation/behavior/lab abn
ormality that may increase the risk of
study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924395
Page 101 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) Exclusio
n Numbe
r:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency vi
rus (HIV), hepatitis C viru
s (HCV), or hepatitis B vi
rus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX02A00
2.b Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human immun
odeficiency virus (HIV), hepatitis C
virus (HCV), or hepatitis B virus (HB
V)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924396
Page 102 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.c
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse re
action associated with a vac
cine and/or severe allergic r
eaction (eg, anaphylaxis) to
any component of the study
intervention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX03A00Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924397
Page 103 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.c Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
History of severe adverse reaction ass
ociated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to
any component of the study intervent
ion(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Des
cription:Receipt of medicatio
ns intended to preve
nt COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924398
Page 104 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.d Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended to pr
event COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Desc
ription:Immunocompromised indi
viduals with known or susp
ected immunodeficiency, a
s determined by history and
/or laboratory/physical exa
mination
Criteri
on met
?:NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924399
Page 105 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on ID: (
For Pfi
zer use
only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals wit
h known or suspected immunodeficie
ncy, as determined by history and/or l
aboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924400
Page 106 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on Desc
ription:Bleeding diathesis or condit
ion associated with prolong
ed bleeding that would, in t
he opinion of the investigat
or, contraindicate intramusc
ular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition assoc
iated with prolonged bleeding that w
ould, in the opinion of the investigato
r, contraindicate intramuscular injecti
onInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924401
Page 107 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.g
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Num
ber:11
Criterion Descr
iption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (
For Pfizer use o
nly):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfe
edingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924402
Page 108 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:12
Criterion Desc
ription:Previous vaccinatio
n with any coronavi
rus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
2.h Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any corona
virus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Exclusion 13Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924403
Page 109 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada) Number:
Criterion
Descripti
on:Subjects who receive im
munosuppressive therapy
, such as cytotoxic agents
or systemic corticosteroi
ds
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppres
sive therapy, such as cytotoxic agents
or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924404
Page 110 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Desc
ription:Receipt of blood/plasma pr
oducts or immunoglobulin,
from 60 days before study i
ntervention administration
or planned receipt througho
ut the study
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX14A01Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924405
Page 111 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.j Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before
study intervention administration or p
lanned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924406
Page 112 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
2.k
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studi
es involving study interve
ntion within 28 days prior
to study entry and/or durin
g study participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX15A01Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924407
Page 113 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.k Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during stu
dy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descripti
on:Previous participation in
other studies involving s
tudy intervention contain
ing lipid nanoparticles
Criterion
met?:NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924408
Page 114 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criterion
ID: (For
Pfizer use
only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous participation in other studie
s involving study intervention contai
ning lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:22Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924409
Page 115 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Criteri
on Des
criptio
n:Investigator site staff or Pfi
zer employees directly invo
lved in the conduct of the st
udy, site staff otherwise sup
ervised by the investigator,
and their respective family
members
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX21A01
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-0924410
Page 116 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.m Exclusion Number:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer emplo
yees directly involved in the conduct
of the study, site staff otherwise supe
rvised by the investigator, and their r
espective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 17:16:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924411
Page 117 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-04-2020 17:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-04-2020 17:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-04-2020 17:16:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924412
Page 118 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 17:17:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:HYPERTENSI
ON
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-04-2020 17:17:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 17:17:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-04-2020 17:17:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-04-2020 17:17:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924413
Page 119 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-04-2020 17:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:HYPERCHOLEST
EROLEMIA
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-04-2020 17:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 17:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-04-2020 17:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-04-2020 17:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-04-2020 17:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:NEPHROLITHI
ASIS
Start Date: Jan/UNK/2019Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924414
Page 120 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-04-2020 17:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 17:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEPHROLITHIASISInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-04-2020 17:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-04-2020 17:19:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-04-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:GASTROESOPHAGE
AL REFLUX DISEAS
E
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924415
Page 121 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.d Line/MH Number:
Date Location User Value Reason
Aug-04-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
GASTROESOPHAGEAL REFLUX
DISEASEInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-04-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-04-2020 17:20:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-04-2020 17:20:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:SLEEP DISTURB
ANCE
Start Date: Jan/UNK/2019
Ongoing: YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924416
Page 122 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.e Line/MH Number:
Date Location User Value Reason
Aug-04-2020 17:20:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 17:20:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SLEEP DISTURBANCEInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-04-2020 17:20:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-04-2020 17:20:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Nov-19-2020 14:19:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Diabetes Mellitus
Type 2
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924417
Page 123 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.f Line/MH Number:
Date Location User Value Reason
Nov-19-2020 14:19:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-19-2020 14:19:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes Mellitus Type 2Initial Entry
1.f Start Date:
Date Location User Value Reason
Nov-19-2020 14:19:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-19-2020 14:19:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Nov-19-2020 14:19:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Coronary Artery
Disease
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924418
Page 124 of 199
***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, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
1.g Line/MH Number:
Date Location User Value Reason
Nov-19-2020 14:19:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-19-2020 14:19:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery DiseaseInitial Entry
1.g Start Date:
Date Location User Value Reason
Nov-19-2020 14:19:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Nov-19-2020 14:19:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924419
Page 125 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
95.25Initial Entry
3. Unit:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
169.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33.3Initial Entry
7.a
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924420
Page 126 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.1
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-04-2020 17:22:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924421
Page 127 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-04-2020 17:22:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020 17:22:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
221835Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924422
Page 128 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 20:30:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 20:30:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020 20:30:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-04-2020 20:30:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-04-2020 20:30:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020 20:30:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3H0MInitial Entry
5.a Sample ID
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924423
Page 129 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-04-2020 20:30:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3H0MInitial Entry
5.b
Date Location User Value Reason
Aug-04-2020 20:31:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3H0NInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-04-2020 20:31:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3H0NInitial Entry
5.c
Date Location User Value Reason
Aug-04-2020 20:31:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3H0PInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-04-2020 20:31:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3H0PInitial Entry
5.d
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924424
Page 130 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-04-2020 20:31:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLH8TInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-04-2020 20:31:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLH8TInitial Entry
5.e
Date Location User Value Reason
Aug-04-2020 20:32:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLH8VInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-04-2020 20:32:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPLH8VInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924425
Page 131 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 20:32:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 20:32:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020 20:32:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-04-2020 20:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-04-2020 20:32:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020 20:32:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3H3VInitial Entry
5.a Sample ID
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924426
Page 132 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-04-2020 20:32:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP3H3VInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924427
Page 133 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2020 12:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924428
Page 134 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-04-2020 17:23:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924429
Page 135 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-04-2020 17:23:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924430
Page 136 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 20:12:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924431
Page 137 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924432
Page 138 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924433
Page 139 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.d
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924434
Page 140 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924435
Page 141 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-25-2020 20:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924436
Page 142 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.h Symptom:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complet
ed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 20:13:25 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924437
Page 143 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern Time
(US & Canada)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITEInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924438
Page 144 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Aug-25-2020 20:13:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924439
Page 145 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 20:14:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2.a
Date Location User Value Reason
Aug-25-2020 20:14:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 20:14:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-25-2020 20:14:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-25-2020 20:14:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924440
Page 146 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Aug-25-2020 20:14:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924441
Page 147 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020 20:15:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020 20:15:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 20:15:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-25-2020 20:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-25-2020 20:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 12:50:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY0JSTranscription Error
Aug-25-2020 20:15:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY0J2Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924442
Page 148 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
5.a Sample ID
Date Location User Value Reason
Aug-27-2020
14:13:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_06
Aug-27-2020
12:50:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription Error
Aug-27-2020
12:50:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
BPY0JSTranscription Error
Aug-27-2020
06:31:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW4357092;The
barcode BPY0J2 is
recorded for two
subjects 11101031
and 11101131, Please
review and update as
appropriate.
Aug-25-2020
20:15:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
BPY0J2Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924443
Page 149 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020 10:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924444
Page 150 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-25-2020 20:14:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924445
Page 151 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020 11:48:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-16-2020 09:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered SAE Diabetes type 2
(hospitalization) reported
on 13Nov2020 was for
subject 1110-1031
Nov-14-2020 11:19:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020451042
diabetes type II(Onset
date:12Nov2020) was
reported in Safety database
for subject 11071065.
However reported as
serious in Inform for
subject 11071026.Please
confirm correct subject
number for the event.
Sep-23-2020 17:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924446
Page 152 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924447
Page 153 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924448
Page 154 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.d
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924449
Page 155 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.e Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924450
Page 156 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924451
Page 157 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
2.h Symptom:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 17:44:37 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924452
Page 158 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00) Eastern
Time (US & Canada)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITEInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924453
Page 159 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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-23-2020 17:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924454
Page 160 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 20:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 20:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 20:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 20:26:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-23-2020 20:26:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 20:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY09PInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924455
Page 161 of 199
***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: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Sep-23-2020 20:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY09PInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 20:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVHMZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 20:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVHMZInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 20:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVHMXInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 20:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVHMXInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924456
Page 162 of 199
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-23-2020 17:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 17:44:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 17:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0924457
Page 163 of 199
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924458
Page 164 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Category:
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-08-2020
17:56:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Clos
edResponse satisfies
query
Nov-30-2020
09:22:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredPI determine that is
the name of the AE
Nov-30-2020
08:07:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reis
sued:OpenedThanks for
confirming. Please
respond to the query
once additional
information is
available. Thanks
Nov-27-2020
15:39:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredPending Medical
Records
Nov-26-2020
00:33:04
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query 2: Clos
edResponse satisfies
query
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924459
Page 165 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(US & Canada)
Nov-25-2020
11:23:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reis
sued:OpenedIf the traumatic
accident was either a
fall or MVA, then fall
and/or MVA needs to
be reported recorded
as AEs as well, even if
an injury did not
result. See specific
CRF completion
guidelines 8.50.2.2.
Please revise and
update AE log
accordingly. Thanks.
Nov-25-2020
08:12:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredBefore the event he
was not taking any
medication for DMII.
As per PI term
reviewed this is
consider Uncontrolled
not worsening.
Nov-24-2020
02:38:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reis
sued:OpenedDM: Event is
'worsening' of existing
condition as per query
response. Per protocol
section 8.50.2.3, if this
is a worsening of the
baseline condition,
"worsening" should be
added to the AE term.
Please review and
consider to update.
Thanks
Nov-23-2020
19:35:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredDone
Nov-23-2020
19:34:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredterm reviewed by PI.
No change was made
Nov-23-2020
02:40:56ACV0PFEINFP6000  Query 4: Clos
edinvalid query
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924460
Page 166 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
(UTC-05:00)
Eastern Time
(US & Canada)
Nov-23-2020
02:40:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Ope
nedSAE RECON:
AER#2020451042,the
term was reported as
'Uncontrolled diabetes
mellitus type II' in
Safety database while
recorded as 'Prostate
Cancer' in AE CRF.
Please confirm correct
term.If safety update
is required, please
submit a follow-up
form.
Nov-23-2020
01:52:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reis
sued:OpenedDM: Please consider
to add 'worsening' to
AE term as per section
8.50.2.3 of completion
guidelines.
Nov-22-2020
15:36:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Reis
sued:OpenedAppreciate the prompt
update. It is also
mentioned that the
subject "passed out".
If this is and
additional event
kindly revise AE log.
Thank you.
Nov-20-2020
17:54:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: Clos
edDiscrepancy has been
closed.
Nov-20-2020
15:44:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Ans
weredTranscription Error
Nov-20-2020
15:44:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Uncontrolled
Diabetes Mell
itus Type 2Transcription Error
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924461
Page 167 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Nov-20-2020
12:21:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: Ope
nedSpacing: Verbatim
Term contains leading,
trailing or more than
one consecutive space.
Nov-20-2020
10:16:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredNew Information
Nov-20-2020
10:16:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Uncontrolled
Diabetes Mell
itus Type 2New Information
Nov-20-2020
10:15:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredit was a worsening
Nov-20-2020
01:37:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ope
nedThe AE Diabetes
Mellitus Type 2 was
reported but is also
listed in Medical
History. Please clarify
if this is a worsening
of the baseline
condition, and if so,
please consider adding
"worsening" to the AE
term.(SDQ)
Nov-19-2020
18:38:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Ope
nedIn case narrative two
additional events have
been described: "he
was spinning class and
passed out" and
"glucose (glu) at 600
mg/dl on arrival to
hospital". Kindly
provide final
diagnosis, revise and
update AE log
accordingly. Thank
you.
Nov-17-2020 ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0924462
Page 168 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
14:47:05
(UTC-05:00)
Eastern Time
(US & Canada)Diabetes Mell
itus Type 2
Nov-16-2020
10:29:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Diabetes Type
2Initial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 19:25:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Updated
Mar-12-2021 08:03:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON:
AER#2020451042,onset
date was updated to
10nOV2020 in AE CRF
however, recorded as
09nOV2020 in Safety
database. Please
confirm correct Onset
Date. If safety update is
required, please submit
a follow-up SAE form.
Mar-11-2021 10:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Mar-11-2021 07:38:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Mar-11-2021 07:38:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/10/2020 UNK:UNKNew Information
Mar-10-2021 17:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened per discharge summary,
subject was admitted on
10Nov20. Pls confirm if
start date should be
updated and revise
source. Pls also submit
SAE FU
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924463
Page 169 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Dec-01-2020 07:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-30-2020 09:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-30-2020 09:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020 UNK:UNKNew Information
Nov-26-2020 06:34:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020451042,onset
date was recorded as
09Nov2020 in Safety
database however,
recorded as 12Nov2020
on AE CRF. Please
confirm correct Onset
Date. If safety update is
required, please submit
a follow-up SAE form.
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-18-2020 07:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/13/2020 UNK:UNKNew Information
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924464
Page 170 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Mar-04-2021 21:40:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Mar-04-2021 17:33:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-04-2021 17:33:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Transcription Error
Mar-04-2021 02:53:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: the module
is unfrozen, please
make change.
Mar-02-2021 09:08:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered please unfreeze to
make correction
Feb-28-2021 13:55:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
reconcile AE grade
and SAE criteria. If
G4, then
life-threatening
criterion should be
checked; or, if not
life-threatening, then
Grade should be 3 or
lower.
Nov-16-2020 12:34:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Transcription Error
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924465
Page 171 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-19-2020 15:49:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response satisfies
query
Nov-19-2020 14:26:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered test was NOT done.
FU was submitted.
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924466
Page 172 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-18-2020 17:32:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened Kindly confirm if
any SARS-CoV-2
(NAAT or other)
tests were performed
on the SAE
submitted to safety.
If test performed =
YES, please provide
FU report with
results. If test was
NOT done or NOT
available, please
submit a FU report as
well. Thanks
Nov-16-2020 11:29:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Diabetes
Type 2: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NOInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924467
Page 173 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-19-2020
23:35:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse
satisfies query
Nov-19-2020
14:33:17
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredDone
Nov-19-2020 ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Ope Please review
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924468
Page 174 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
07:46:02
(UTC-05:00)
Eastern Time
(US & Canada)ned "If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [diabetes
mellitus]. Any
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. Please
review and
update as
necessary.
Nov-16-2020
12:35:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELAT
ED
If Not Relat
ed to study t
reatment(s),
this event is
due to:
OTHER
If Other,
specify:
diabetes
mellitus
type 2 u
ncontro
lledTranscription
Error
Nov-16-2020
10:29:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELAT
ED
If Not Relat
ed to study t
reatment(s),
this event is
due to:Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0924469
Page 175 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
OTHER
If Other,
specify:
unknow
n
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-16-2020 20:50:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-16-2020 15:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-16-2020 15:41:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Nov-16-2020 13:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jason Hill Query 1: Opened CRA) Source
indicates that a
non-drug treatment
was given. Please
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0924470
Page 176 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
verify and correct
EDC/Source
accordingly.
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Jan-25-2021
11:40:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Del
etedUpdated in SDB
Nov-18-2020
09:08:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
Nov-18-2020
07:40:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredupdated
Nov-17-2020
21:32:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW5406412;Response
to "What was the outcome
of this adverse event?" is
'Recovered/Resolved' or
'Recovered/Resolved with
Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Nov-17-2020
15:38:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Can
didatePending SDB update
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924471
Page 177 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Nov-17-2020
14:46:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RED/
RESO
LVEDNew Information
Nov-16-2020
18:33:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-16-2020
12:35:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Nov-16-2020
12:35:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGTranscription Error
Nov-16-2020
11:31:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2020451042
outcome was reported as
Recovering/Resolving to
Safety DB however,
recorded as NOT
RECOVERED/NOT
RESOLVED on AE CRF.
Please confirm correct
outcome. If safety update is
required, please submit a
follow-up form.
Nov-16-2020
10:29:23
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Data
Entry
:
NOT
RECInitial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (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-2021-5683-0924472
Page 178 of 199
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Canada) OVE
RED/
NOT
RESO
LVED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-16-2020 10:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-16-2020 11:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020451042Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0924473
Page 179 of 199
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-04-2021 17:58:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/31/2020Initial Entry
090177e196ae3da0\Final\Final On: 01-Apr-2021 04:40 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0924474
Page 180 of 199
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1110 Site Name: (1110) Clinical Research of South Florida
Subject No: 11101031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:49
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-30-2021 10:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-26-2021 13:25:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered UPDATED
Jan-25-2021 20:47:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Pls document in
source how subject
met eligibility for
unblinding
Jan-04-2021 17:59:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-04-2021 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-04-2021 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant
…[truncated]