Document text
Page 1 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971220
Page 2 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971221
Page 3 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10971026]
2.Birth Date: 1939
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:
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971222
Page 4 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971223
Page 5 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971224
Page 6 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971225
Page 7 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypogonadism]
Start Date: Dec/9/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Congestive Heart Failure]
Start Date: Aug/21/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Systolic Heart Failure]
Start Date: Apr/13/2020
Ongoing: YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971226
Page 8 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Essential Hypertension]
Start Date: Jun/27/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obstructive Sleep Apnea]
Start Date: May/16/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: May/16/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Foot Drop]
Start Date: May/16/2018
Ongoing: YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971227
Page 9 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Normal Pressure hydrocephalus]
Start Date: May/16/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depressive Disorder]
Start Date: May/15/2018
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: May/15/2020
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: May/15/2020
Ongoing: YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971228
Page 10 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BPH]
Start Date: May/15/2018
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: Apr/10/2018
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atrial Fibrillation]
Start Date: Apr/10/2018
Ongoing: YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971229
Page 11 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [220.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [30.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971230
Page 12 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [238173]
3.Randomization Group: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971231
Page 13 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6BCH]
5.bSample ID [BN6BBN]
5.cSample ID [BL9X6J]
5.dSample ID [BL9X6K]
5.eSample ID [BN6BBP]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971232
Page 14 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6BBD]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971233
Page 15 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/24/2020 13:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971234
Page 16 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971235
Page 17 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971236
Page 18 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971237
Page 19 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971238
Page 20 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971239
Page 21 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971240
Page 22 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6BHR]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971241
Page 23 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/14/2020 11:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971242
Page 24 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971243
Page 25 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971244
Page 26 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971245
Page 27 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971246
Page 28 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVCF8]
5.bSample ID [BPVCF9]
5.cSample ID [BPVCFB]
5.dSample ID [BL9XC8]
5.eSample ID [BL9XC9]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971247
Page 29 of 236
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971248
Page 30 of 236
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971249
Page 31 of 236
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971250
Page 32 of 236
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971251
Page 33 of 236
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971252
Page 34 of 236
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971253
Page 35 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971254
Page 36 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971255
Page 37 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971256
Page 38 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971257
Page 39 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971258
Page 40 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971259
Page 41 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971260
Page 42 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971261
Page 43 of 236
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 CEREBROVASCU
LAR ACCIDENT Feb/24/2021
UNK:UNK YES Repeating
Pages
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971262
Page 44 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[CEREBROVASCULAR ACCIDENT]
4.Start Date Time: Feb/24/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971263
Page 45 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown at this time]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971264
Page 46 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021225597]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971265
Page 47 of 236
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication E
rrors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971266
Page 48 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971267
Page 49 of 236
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971268
Page 50 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: //
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971269
Page 51 of 236
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971270
Page 52 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971271
Page 53 of 236
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryTreatment Ide
ntifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971272
Page 54 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971273
Page 55 of 236
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971274
Page 56 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971275
Page 57 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971276
Page 58 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971277
Page 59 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971278
Page 60 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971279
Page 61 of 236
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971280
Page 62 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971281
Page 63 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971282
Page 64 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971283
Page 65 of 236
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date
://
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971284
Page 66 of 236
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971285
Page 67 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971286
Page 68 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971287
Page 69 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971288
Page 70 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971289
Page 71 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
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 [BP2RSW]
5.bSample ID [BP2RSY]
5.cSample ID [BP2RSX]
5.dSample ID [BHGTDR]
5.eSample ID [BHGTDS]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971290
Page 72 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
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 [BP2RSG]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971291
Page 73 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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/18/2021 12:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971292
Page 74 of 236
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971293
Page 75 of 236
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP2RZS]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971294
Page 76 of 236
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 11:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971295
Page 77 of 236
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971296
Page 78 of 236
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [Subject is currently in the hospital on the rehab floor. SAE
previously submitted. Conducted phone visit with wife by his
side.]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971297
Page 79 of 236
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971298
Page 80 of 236
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971299
Page 81 of 236
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971300
Page 82 of 236
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971301
Page 83 of 236
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971302
Page 84 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971303
Page 85 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971304
Page 86 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tom
Christensen Approved Mar-09-2021 14:21:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971305
Page 87 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-25-2020 12:25:53 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971306
Page 88 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormJan-18-2021 15:16:49 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971307
Page 89 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Tom
Christensen Approved Mar-09-2021 14:21:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Mar-09-2021 08:18:56 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Mar-09-2021 07:40:34 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971308
Page 90 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
By my dated signature below, I, TomChristensen, 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-03-2021 05:27:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Mar-02-2021 12:06:49 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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-01-2021 15:46:36 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971309
Page 91 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
N/A
Tom
Christensen Approved Feb-24-2021 16:27:01 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Feb-08-2021 12:24:15 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Jan-20-2021 20:38:11 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0971310
Page 92 of 236
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
By my dated signature below, I, TomChristensen, 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-18-2021 15:15:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Tom
Christensen Approved Oct-22-2020 16:17:50 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TomChristensen, 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.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971311
Page 93 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020
12:24:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020
12:24:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971312
Page 94 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020
12:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/24/2020Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971313
Page 95 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020
12:24:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10971026Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020
12:24:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1939Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020
12:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020
12:25:25ACV0PFEINFP6000 Data Entry:
NOT HISPANIC ORInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971314
Page 96 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-05:00)
Eastern Time (US
& Canada)LATINO(A) OR OF
SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020
12:25:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971315
Page 97 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020
12:25:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971316
Page 98 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020
12:26:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020
12:26:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020
12:26:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971317
Page 99 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020
12:27:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Hypogon
adism
Start Date: Dec/9/20
19
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:27:21
(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-25-2020
12:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypogonadismInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971318
Page 100 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.a Start Date:
Date Location User Value Reason
Aug-25-2020
12:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Dec/9/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020
12:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-25-2020
12:28:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical Hi
story Term
:Congestive
Heart Failu
re
Start Date: Aug/21/201
8
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971319
Page 101 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:28:03
(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-25-2020
12:28:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Congestive Heart Fail
ureInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020
12:28:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/21/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020
12:28:03
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971320
Page 102 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.c
Date Location User Value Reason
Aug-25-2020
12:28:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term:Systolic H
eart Failur
e
Start Date: Apr/13/20
20
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971321
Page 103 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:28:40
(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-25-2020
12:28:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Systolic Heart FailureInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020
12:28:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Apr/13/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020
12:28:40
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971322
Page 104 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.d
Date Location User Value Reason
Aug-25-2020
12:29:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical Hi
story Term
:Essential H
ypertensio
n
Start Date: Jun/27/201
8
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971323
Page 105 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:29:12
(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-25-2020
12:29:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Essential Hypertensio
nInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020
12:29:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jun/27/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020
12:29:12
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971324
Page 106 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.e
Date Location User Value Reason
Aug-25-2020
12:29:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Obstructive
Sleep Apne
a
Start Date: May/16/20
18
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971325
Page 107 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:29:44
(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-25-2020
12:29:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Obstructive Sleep Ap
neaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020
12:29:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/16/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020
12:29:44
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971326
Page 108 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.f
Date Location User Value Reason
Aug-25-2020
12:31:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Hyperlipi
demia
Start Date: May/16/
2018
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971327
Page 109 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:31:21
(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
Aug-25-2020
12:31:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020
12:31:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/16/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020
12:31:21
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971328
Page 110 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.g
Date Location User Value Reason
Aug-25-2020
12:31:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Right Fo
ot Drop
Start Date: May/16/2
018
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971329
Page 111 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.g Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:31:51
(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
Aug-25-2020
12:31:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Right Foot DropInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020
12:31:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/16/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020
12:31:51
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971330
Page 112 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.h
Date Location User Value Reason
Aug-25-2020
12:32:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:Normal Pres
sure hydroce
phalus
Start Dat
e:May/16/201
8
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971331
Page 113 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.h Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:32:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:32:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Normal Pressure hydr
ocephalusInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-25-2020
12:32:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/16/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020
12:32:32
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971332
Page 114 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.i
Date Location User Value Reason
Aug-25-2020
12:33:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical His
tory Term:Depressiv
e Disorder
Start Date: May/15/20
18
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971333
Page 115 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.i Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:33:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:33:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Depressive DisorderInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-25-2020
12:33:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/15/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-25-2020
12:33:06
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971334
Page 116 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
1.j
Date Location User Value Reason
Aug-25-2020
12:33:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:Hypothyr
oidism
Start Date: May/15/2
020
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971335
Page 117 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.j Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:33:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:33:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-25-2020
12:33:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/15/2020Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-25-2020
12:33:44
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971336
Page 118 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971337
Page 119 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.k
Date Location User Value Reason
Aug-25-2020
12:34:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:Osteoart
hritis
Start Date: May/15/
2020
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971338
Page 120 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.k Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:34:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:34:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OsteoarthritisInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-25-2020
12:34:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/15/2020Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-25-2020
12:34:18
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971339
Page 121 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
1.l
Date Location User Value Reason
Aug-25-2020
12:42:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:BPH
Start Date: May/15/
2018
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971340
Page 122 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.l Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:42:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:42:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPHInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-25-2020
12:42:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
May/15/2018Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-25-2020
12:42:16
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971341
Page 123 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
1.m
Date Location User Value Reason
Aug-25-2020
12:42:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Histo
ry Term:GERD
Start Date: Apr/10/
2018
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971342
Page 124 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.m Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:42:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:42:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-25-2020
12:42:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Apr/10/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-25-2020
12:42:45
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971343
Page 125 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
1.n
Date Location User Value Reason
Aug-25-2020
12:43:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Hist
ory Term:Atrial Fib
rillation
Start Date: Apr/10/2
018
Ongoing: YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971344
Page 126 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.n Line/MH Number:
Date Location User Value Reason
Aug-25-2020
12:43:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
12:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Atrial FibrillationInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-25-2020
12:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Apr/10/2018Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-25-2020
12:43:07
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971345
Page 127 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971346
Page 128 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
220.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971347
Page 129 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.7Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.5Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971348
Page 130 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971349
Page 131 of 236
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
12:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971350
Page 132 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020
12:45:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020
12:45:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
238173Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971351
Page 133 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
12:45:45
(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
12:45:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020
06:20:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Sep-05-2020
14:36:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Added
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971352
Page 134 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-04-2020
17:00:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened DM: Barcode
BN6BBP is
missing in
inform. Please
review and
update
accordingly or
clarify.
Aug-25-2020
12:46:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
12:45:45
(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
12:45:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
12:46:43
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN6BC
HInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971353
Page 135 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
12:46:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN6BCHInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020
12:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN6BB
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020
12:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN6BBNInitial Entry
5.c
Date Location User Value Reason
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971354
Page 136 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-25-2020
12:47:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BL9X6
JInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020
12:47:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BL9X6JInitial Entry
5.d
Date Location User Value Reason
Aug-25-2020
12:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BL9X6
KInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-25-2020
12:48:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BL9X6KInitial Entry
5.e
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971355
Page 137 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Sep-05-2020
14:36:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN6BB
PInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-05-2020
14:36:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN6BBPInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971356
Page 138 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
12:48:20
(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
12:48:20
(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
12:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
12:48:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971357
Page 139 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Please review
and correct as
appropriate.
Aug-25-2020
12:48:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
12:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN6BB
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
12:48:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN6BBDInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971358
Page 140 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020
12:52:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020
12:52:00
(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
12:52:00
(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
12:52:00ACV0PFEINFP6000 Data Entry:
Aug/24/2020 13:05Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971359
Page 141 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
12:52:00
(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
12:52:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
12:52:00
(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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971360
Page 142 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-25-2020
12:52:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-25-2020
12:52:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971361
Page 143 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-02-2020
04:18:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-01-2020
17:48:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redTranscription Error
Sep-01-2020
17:48:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACT
OGENICITY E
-DIARY COLL
ECTED FOR T
HIS SUBJECTTranscription Error
Sep-01-2020
06:50:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
deDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'No' however VAX 1
eDiary records are
available for the
subject. Please verify
and update. Else,
confirm in query
response
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971362
Page 144 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
appropriately.
Aug-25-2020
12:52:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTO
GENICITY E-
DIARY NOT C
OLLECTED F
OR THIS SUBJ
ECTInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971363
Page 145 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-22-2020
12:57:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971364
Page 146 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971365
Page 147 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971366
Page 148 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.b Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971367
Page 149 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.c Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
L
S
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971368
Page 150 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.d Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971369
Page 151 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.e Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971370
Page 152 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.f Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971371
Page 153 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED 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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSEInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971372
Page 154 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada) NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971373
Page 155 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-22-2020
12:58:15
(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-22-2020
13:01:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-22-2020
13:01:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTTranscription
Error
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Injection Site
Body Side
entered on this
page is not
matching with
Body Side
entered on
Vaccination
page of
V1D1VX1L.
Please review
and update as
appropriate.
Sep-22-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971374
Page 156 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)RIGHT
5.a
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020
12:58:15ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971375
Page 157 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-05:00)
Eastern Time (US
& Canada)
5.b
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971376
Page 158 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020
12:58:15
(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-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAI
N AT
INJE
CTI
ON
SITEInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971377
Page 159 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020
12:58:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971378
Page 160 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020
12:58:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020
12:58:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.9
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020
12:58:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971379
Page 161 of 236
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.a Temperature:
Date Location User Value Reason
Sep-22-2020
12:58:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020
12:58:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-22-2020
12:58:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971380
Page 162 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020
13:02:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020
13:02:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020
13:04:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
13:02:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971381
Page 163 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Please review
and correct as
appropriate.
Sep-22-2020
13:02:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020
13:04:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BN6BH
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
13:04:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN6BHRInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971382
Page 164 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020
13:05:17ACV0PFEINFP6000 Data Entry:
Sep/14/2020 11:52Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971383
Page 165 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-05:00)
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-22-2020
13:05:17
(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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971384
Page 166 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION
PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-22-2020
13:05:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971385
Page 167 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-18-2020
05:53:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-16-2020
08:59:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Completed
EOT
Oct-16-2020
06:06:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: Patient
completed the
treatment
phase and
reached at
Visit 3. Kindly
consider to
update EOT
form with
matching V3
date or else
clarify. Thank
you.
Oct-14-2020
15:15:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971386
Page 168 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
V
E
R
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971387
Page 169 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:N
OInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971388
Page 170 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.b Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971389
Page 171 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.c Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
LL
S
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:N
OInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971390
Page 172 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.d Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971391
Page 173 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.e Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971392
Page 174 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
2.f Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PAI
NInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971393
Page 175 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED JInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971394
Page 176 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
OINT
PAIN
Were fever or
systemic symp
toms present o
n the last day
the Subject Di
ary was compl
eted?:NO
2.h Symptom:
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED
JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971395
Page 177 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US &
Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Rea
ction::RE
D
NE
SS
Were injection sit
e reactions presen
t on the last day t
he Subject Diary
was completed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971396
Page 178 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::SW
EL
LIN
G
Were injection si
te reactions prese
nt on the last day
the Subject Diar
y was completed
?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971397
Page 179 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::PAIN
AT I
NJEC
TION
SITE
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971398
Page 180 of 236
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-14-2020
15:15:55
(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
Oct-14-2020
15:15:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971399
Page 181 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020
15:16:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020
15:16:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020
15:24:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
15:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971400
Page 182 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
review and
correct as
appropriate.
Oct-14-2020
15:16:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
15:24:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVCF8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
15:24:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPVCF8Initial Entry
5.b
Date Location User Value Reason
Oct-14-2020
15:24:56
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVCF9Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971401
Page 183 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Eastern Time (US
& Canada)
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
15:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPVCF9Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020
15:25:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVCFBInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
15:25:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPVCFBInitial Entry
5.d
Date Location User Value Reason
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971402
Page 184 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Oct-14-2020
15:25:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9XC8Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020
15:25:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BL9XC8Initial Entry
5.e
Date Location User Value Reason
Oct-14-2020
15:26:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9XC9Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-14-2020
15:26:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BL9XC9Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971403
Page 185 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020
08:59:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020
08:59:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020
08:59:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971404
Page 186 of 236
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971405
Page 187 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-01-2021
15:46:36
(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
Mar-12-2021
13:56:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered updated SAE
report and
faxing in
3/12/2021
Mar-12-2021
13:23:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Reissued:
OpenedClinical Thank
you, however
the 09Mar21
SAE report did
not include the
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971406
Page 188 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vax 1
(24Aug20) and
Vax 2 (14Sep20)
in the SAE Past
Med Hx. Please
submit these in a
SAE safety
update.
Mar-11-2021
08:51:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered Update was
faxed in on
3/9/2021.
Mar-10-2021
14:43:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - the
09Mar21 SAE
update only
reports study
vaccinations in
2021; missing
(on med Hx, like
18Jan21 VAX3)
are VAX 1 & 2
in August and
Sept 2020. This
must be
submitted;
please update
ASAP
Mar-09-2021
09:02:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Query closed;
will follow for
requested VAX
date
information.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971407
Page 189 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-09-2021
08:18:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Will update
today.
Mar-09-2021
00:54:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedClinical - Thank
you; however
03Mar21 SAE
report does NOT
include VAX 1
(24Aug20) or
VAX 2
(14Sep20) -
please submit
these study
vaccinations
ASAP
Mar-05-2021
22:08:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Query closed;
will follow for
requested
clinical data
information.
Mar-04-2021
11:20:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered records still
pending, as
subject is still in
the hosptial
Mar-04-2021
11:20:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered faxed
information in
on 3/03/2021
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (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-2021-5683-0971408
Page 190 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-04-2021
09:20:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - please
submit a SAE
followup with
clinical data on
BP,
anticoagulation
labs, imaging
and other
relevant
information on
event, and
treatment
Mar-04-2021
09:13:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - please
submit a SAE
update reporting
ALL doses of
study
medication ie
report dates for
VAX1 and
VAX2
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CEREBROVASCU
LAR ACCIDENTInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Feb/24/2021 UNK:UN
KInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971409
Page 191 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-01-2021
15:46:36
(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 medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Mar-05-2021
22:02:26
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query 2: Clos
edQuery closed; will
follow for requested
COVID test
information.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971410
Page 192 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US & Canada)
Mar-05-2021
07:51:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ans
weredpt is still in the hospital,
we have no records yet,
we will update once pt
is discharged and site
has records
Mar-05-2021
00:55:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ope
nedClinical COVID test
status (yes/no) during
Hosp was not reported
in the SAE. Please
submit a follow-up SAE
form [#2021225597] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes, the
date and results.
Mar-04-2021
09:21:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Can
didateClinical COVID test
status (yes/no) during
Hosp was not reported
in the SAE. Please
submit a follow-up SAE
form [#2021225597] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes, the
date and results.
Mar-03-2021
05:27:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Dele
tedClose Auto Query
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971411
Page 193 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Can
didateFor AE
CEREBROVASCULAR
ACCIDENT: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this seriou
s event asso
ciated with c
ongenital an
omaly or bir
th defect?
NO
Did this seri
ous event re
sult in death
?
NO
Did this seri
ous event re
quire or prol
ong hospital
ization?
YES
Did this seri
ous event reInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971412
Page 194 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
sult in persis
tent or signif
icant disabil
ity/incapacit
y?
NO
Is this seriou
s event life t
hreatening?
NO
Other medic
ally importa
nt serious ev
ent
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
Mar-01-2021
15:46:36
(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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971413
Page 195 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-04-2021
10:46:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Deleted Changed
Information
Mar-04-2021
10:46:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, specif
y:
unknown at t
his timeChanged
Information
Mar-02-2021
11:45:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:
CandidatePer site response,
"AS
SUBMITTED IN
THE SAE,
MEDICAL
RECORDS ARE
CURRENTLY
NOT
AVAILABLE.
SUBJECT IS
STILL
HOSPITALIZED
AND WE ARE
REPORTING
WITH WIFE'S
NARRATIVE.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971414
Page 196 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
WILL UPDATE
WHEN INFO IS
AVAILABLE."
Mar-02-2021
08:44:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dAS
SUBMITTED IN
THE SAE,
MEDICAL
RECORDS ARE
CURRENTLY
NOT
AVAILABLE.
SUBJECT IS
STILL
HOSPITALIZED
AND WE ARE
REPORTING
WITH WIFE'S
NARRATIVE.
WILL UPDATE
WHEN INFO IS
AVAILABLE.
Mar-01-2021
23:42:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for "Is
this event related
to study
treatment" Is
reported as 'Not
Related', however
response for,
'Please indicate
what this event is
due to' is missing.
Kindly review
and update.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0971415
Page 197 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021
09:01:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-09-2021
08:18:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
Mar-09-2021
08:18:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971416
Page 198 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-09-2021
00:47:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed duplicate
Mar-09-2021
00:47:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - for data
lock, please enter
'NO' con med;
which can be
revised with
receipt of medical
records
Mar-09-2021
00:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedClinical - for data
lock, please enter
'NO' con med;
which can be
revised with
receipt of medical
records
Mar-08-2021
09:07:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered As previously
stated, we do not
have hospital
records at this
time. Subject is
still hospitalized.
We can assume
that he was
treated with some
type of
concomitant
medication, but
we do not know
that to be fact.
Will update.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971417
Page 199 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-08-2021
05:12:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedDM 1: Thank you
for the response,
however the
response for
"Was a
Concomitant
Medication
given?" is not
updated yet,
please review and
update, else
clarify.
Mar-02-2021
11:45:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
CandidatePer site response,
AS SUBMITTED
IN THE SAE,
MEDICAL
RECORDS ARE
CURRENTLY
NOT
AVAILABLE.
SUBJECT IS
STILL
HOSPITALIZED
AND WE ARE
REPORTING
WITH WIFE'S
NARRATIVE.
WILL UPDATE
WHEN INFO IS
AVAILABLE.
Mar-02-2021
08:43:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered AS SUBMITTED
IN THE SAE,
MEDICAL
RECORDS ARE
CURRENTLY
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0971418
Page 200 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
NOT
AVAILABLE.
SUBJECT IS
STILL
HOSPITALIZED
AND WE ARE
REPORTING
WITH WIFE'S
NARRATIVE.
WILL UPDATE
WHEN INFO IS
AVAILABLE.
Mar-01-2021
23:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Was a
Concomitant
Medication
given?" is
missing. Kindly
review and
update
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021
09:01:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-09-2021
08:18:56
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971419
Page 201 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
& Canada)
Mar-09-2021
08:18:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
Mar-09-2021
04:26:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Open query
Mar-09-2021
00:48:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - for
data lock, please
enter 'NO'
non-medication
treatment; which
can be revised
with receipt of
medical records
Mar-08-2021
09:07:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered As previously
stated, we do not
have hospital
records at this
time. Subject is
still hospitalized.
We can assume
that he was
treated with
some type of
concomitant
medication, but
we do not know
that to be fact.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0971420
Page 202 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Will update.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971421
Page 203 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
05:09:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
OpenedDM 1: Thank you
for the response,
however the
response for
"Was a Non-Drug
Treatment
given?" is not
updated yet,
please review and
update, else
clarify.
Mar-02-2021
11:46:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Reissued:
CandidatePer site response,
AS
SUBMITTED IN
THE SAE,
MEDICAL
RECORDS ARE
CURRENTLY
NOT
AVAILABLE.
SUBJECT IS
STILL
HOSPITALIZED
AND WE ARE
REPORTING
WITH WIFE'S
NARRATIVE.
WILL UPDATE
WHEN INFO IS
AVAILABLE.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0971422
Page 204 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-02-2021
08:44:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered AS
SUBMITTED IN
THE SAE,
MEDICAL
RECORDS ARE
CURRENTLY
NOT
AVAILABLE.
SUBJECT IS
STILL
HOSPITALIZED
AND WE ARE
REPORTING
WITH WIFE'S
NARRATIVE.
WILL UPDATE
WHEN INFO IS
AVAILABLE.
Mar-01-2021
23:43:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Was a Non-Drug
Treatment
given?" is
missing. Kindly
review and
update.
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-12-2021
10:20:12
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query
2: An
swere
dThat update was sent in error and a
corrected one was sent after it.
Subject IS NOT recovered and is
currently still in the hospital. He has
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971423
Page 205 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(US &
Canada)been moved to a rehab floor and is
doing better but not recovered.
Mar-12-2021
10:01:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedSAE
RECON:AER#2021225597,outcome
was reported as
RECOVERED/RESOLVED WITH
SEQUELAE to Safety DB however,
recorded as UNKNOWN on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Mar-03-2021
06:40:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Mar-02-2021
08:44:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dAS SUBMITTED IN THE SAE,
MEDICAL RECORDS ARE
CURRENTLY NOT AVAILABLE.
SUBJECT IS STILL
HOSPITALIZED AND WE ARE
REPORTING WITH WIFE'S
NARRATIVE. WILL UPDATE
WHEN INFO IS AVAILABLE.
Mar-02-2021
06:01:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Open
edDM 1: Thank you for the response
however please discuss with subject
CRA and try to update the outcome
of this adverse event.
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0971424
Page 206 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-01-2021
15:50:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dSAE WAS REPORTED ON A
NARRATIVE FROM SUBJECTS
WIFE. RECORDS HAVE NOT
BEEN RECEIVED, SO OUTCOME
IS UNKNOWN AT THIS
TIME.SUBJECT IS IN THE
HOSPITAL, SO IT IS STILL
ONGOING.
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Op
enedFor AE CEREBROVASCULAR
ACCIDENT: Response to "What
was the outcome of this adverse
event?" is 'Unknown' but End
Date/Time is provided or "Is the
adverse event still ongoing?" is
marked "Yes".
Mar-01-2021
15:46:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
UNK
NOW
NInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-01-2021
15:46:36
(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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971425
Page 207 of 236
***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
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-03-2021
05:27:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021225597Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0971426
Page 208 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021
15:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971427
Page 209 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021
11:23:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Jan-19-2021
06:39:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-18-2021
15:15:24
(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
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971428
Page 210 of 236
***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: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
date.
Jan-18-2021
15:15:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible per local/
national recomme
ndations and conf
irmed to have rec
eived only placeb
o at Vaccination 1
/2Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971429
Page 211 of 236
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
11:23:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
11:23:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0971430
Page 212 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021
15:16:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971431
Page 213 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-18-2021
15:16:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Jan/18/2021Initial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971432
Page 214 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-18-2021
15:17:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-18-2021
15:17:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-18-2021
15:17:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0971433
Page 215 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021
15:17:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021
15:17:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-18-2021
16:29:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-18-2021
15:17:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0971434
Page 216 of 236
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1097 Site Name: (1097) Main Street Physician's Care - Waterway
Subject No: 10971026 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
review and
correct as
appropriate.
Jan-18-2021
15:17:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/18/2021Initial Entry
5.a
Date Location User Value Reason
Jan-18-2021
16:29:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RSWInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-18-2021
16:29:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP2RSWInitial Entry
5.b
Date Location User Value Reason
Jan-18-2021
16:30:39
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample ID: BP2RSYInitial Entry
090177e196ae3ebd\Final\Final On: 01-Apr-2021 04:59 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-09
…[truncated]