Document text
Page 1 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954832
Page 2 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/7/2020
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954833
Page 3 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10791076]
2.Birth Date: /1961
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954834
Page 4 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954835
Page 5 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954836
Page 6 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954837
Page 7 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II Diabetes]
Start Date: UNK/UNK/1989
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954838
Page 8 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hot Flahses]
Start Date: Jul/UNK/2020
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Blind (R - Eye)]
Start Date: UNK/UNK/2014
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post-Menopausal]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954839
Page 9 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [211.2]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [36.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954840
Page 10 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954841
Page 11 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [223894]
3.Randomization Group: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954842
Page 12 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/7/2020
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 [BMPYHD]
5.bSample ID [BMPYHF]
5.cSample ID [BNBCJP]
5.dSample ID [BNBCJR]
5.eSample ID [BNBCJS]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954843
Page 13 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/7/2020
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 [BNBCJ5]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954844
Page 14 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/7/2020 10:48
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954845
Page 15 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS
SUBJECT
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954846
Page 16 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954847
Page 17 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954848
Page 18 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954849
Page 19 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954850
Page 20 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954851
Page 21 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954852
Page 22 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPXVMF]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954853
Page 23 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/28/2020 09:27
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954854
Page 24 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954855
Page 25 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954856
Page 26 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was
completed?NO
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954857
Page 27 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954858
Page 28 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BPB0P7]
5.bSample ID [BLG0S6]
5.cSample ID [BLG0RP]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954859
Page 29 of 209
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954860
Page 30 of 209
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
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 [BS236D]
5.bSample ID [BRN1GR]
5.cSample ID [BS236N]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954861
Page 31 of 209
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954862
Page 32 of 209
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954863
Page 33 of 209
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954864
Page 34 of 209
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954865
Page 35 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954866
Page 36 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954867
Page 37 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954868
Page 38 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954869
Page 39 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954870
Page 40 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954871
Page 41 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954872
Page 42 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954873
Page 43 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954874
Page 44 of 209
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954875
Page 45 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954876
Page 46 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954877
Page 47 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954878
Page 48 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954879
Page 49 of 209
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ident
ifierAdverse E
ventStart DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Uterine Ca
ncer Jan/25/2021 UN
K:UNK YES Repeating
Pages
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954880
Page 50 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[Uterine Cancer]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
NO
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954881
Page 51 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
[Unopposed ERT]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2021187485]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954882
Page 52 of 209
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categ
oryMedication
ErrorStart D
ateIs the medication error S
till OngoingStudy Medication Err
ors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954883
Page 53 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954884
Page 54 of 209
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954885
Page 55 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954886
Page 56 of 209
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954887
Page 57 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954888
Page 58 of 209
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-
specifiedTreatme
ntStart D
ateForm Instance
1. Repeating
Pages
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954889
Page 59 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954890
Page 60 of 209
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954891
Page 61 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954892
Page 62 of 209
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954893
Page 63 of 209
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954894
Page 64 of 209
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954895
Page 65 of 209
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954896
Page 66 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954897
Page 67 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954898
Page 68 of 209
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954899
Page 69 of 209
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954900
Page 70 of 209
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954901
Page 71 of 209
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954902
Page 72 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954903
Page 73 of 209
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954904
Page 74 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954905
Page 75 of 209
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954906
Page 76 of 209
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954907
Page 77 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/29/2020
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954908
Page 78 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954909
Page 79 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad Approved Mar-10-2021 18:41:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954910
Page 80 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-07-2020 16:34:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954911
Page 81 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954912
Page 82 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Aug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954913
Page 83 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Aug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954914
Page 84 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Aug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954915
Page 85 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Aug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954916
Page 86 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Aug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954917
Page 87 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954918
Page 88 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954919
Page 89 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-07-2020 14:19:50 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954920
Page 90 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954921
Page 91 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Aug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954922
Page 92 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Aug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954923
Page 93 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Aug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954924
Page 94 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Aug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954925
Page 95 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Aug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954926
Page 96 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954927
Page 97 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954928
Page 98 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aAug-31-2020 20:25:11 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954929
Page 99 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-23-2020 09:18:58 (UTC-05:00)
Eastern Time (US & Canada)
4Sep-29-2020 16:19:18 (UTC-05:00)
Eastern Time (US & Canada)NA
Not Applicable
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954930
Page 100 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad Approved Mar-10-2021 18:41:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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-22-2021 18:04:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad Approved Jan-22-2021 10:13:50 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954931
Page 101 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, GeorgeRaad, 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-21-2021 16:49:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad Approved Oct-27-2020 13:06:05 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend
that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Oct-23-2020 09:18:58 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954932
Page 102 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
George Raad Approved Oct-12-2020 11:17:41 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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 Sep-29-2020 16:18:18 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad Approved Sep-16-2020 14:54:14 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, 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.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954933
Page 103 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-07-2020
14:05:55
(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-07-2020
14:05:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954934
Page 104 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020
14:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent O
btained
Aug/7/2020Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954935
Page 105 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020
14:05:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10791076Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-07-2020
14:05:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1961Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020
14:06:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-07-2020
14:06:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LAT
INO(A) OR OF SPANIS
H ORIGINInitial Entry
5. Race: (Check X all that apply):
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954936
Page 106 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-07-2020
14:06:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN
AMERICANInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954937
Page 107 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-07-2020
14:13:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954938
Page 108 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-07-2020
14:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-07-2020
14:13:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-07-2020
14:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954939
Page 109 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-07-2020
14:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Hyperchole
sterolemia
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:14:27
(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-07-2020
14:14:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954940
Page 110 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-07-2020
14:14:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-07-2020
14:14:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-07-2020
14:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:Type II Di
abetes
Start Date: UNK/UN
K/1989
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954941
Page 111 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:14:53
(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-07-2020
14:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type II DiabetesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-07-2020
14:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1989Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-07-2020
14:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954942
Page 112 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c
Date Location User Value Reason
Aug-07-2020
14:15:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:Depressio
n
Start Date: UNK/UN
K/2005
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954943
Page 113 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:15:12
(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-07-2020
14:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-07-2020
14:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-07-2020
14:15:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954944
Page 114 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d
Date Location User Value Reason
Aug-07-2020
14:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:GERD
Start Date: UNK/UN
K/2015
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954945
Page 115 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:15:32
(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-07-2020
14:15:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-07-2020
14:15:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-07-2020
14:15:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954946
Page 116 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e
Date Location User Value Reason
Aug-07-2020
14:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:Hypertens
ion
Start Date: UNK/UN
K/2015
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954947
Page 117 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:16:14
(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-07-2020
14:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-07-2020
14:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-07-2020
14:16:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954948
Page 118 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f
Date Location User Value Reason
Aug-07-2020
14:17:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:Hot Flahs
es
Start Date: Jul/UNK/
2020
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954949
Page 119 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:17:15
(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-07-2020
14:17:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Hot FlahsesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-07-2020
14:17:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-07-2020
14:17:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954950
Page 120 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g
Date Location User Value Reason
Aug-07-2020
14:18:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Blind (R -
Eye)
Start Date: UNK/UN
K/2014
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954951
Page 121 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:18:05
(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-07-2020
14:18:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Blind (R - Eye)Initial Entry
1.g Start Date:
Date Location User Value Reason
Aug-07-2020
14:18:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-07-2020
14:18:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954952
Page 122 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.h
Date Location User Value Reason
Aug-07-2020
14:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:Post-Meno
pausal
Start Date: UNK/UN
K/2005
Ongoing: YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954953
Page 123 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.h Line/MH Number:
Date Location User Value Reason
Aug-07-2020
14:18:39
(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-07-2020
14:18:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Post-MenopausalInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-07-2020
14:18:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-07-2020
14:18:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954954
Page 124 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
211.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
64.0Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954955
Page 125 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
5. Unit:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.2Initial Entry
7.a
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:97.6
Temperature
Unit:F
Temperature
Location::FORE
HEADInitial Entry
7.a Record Identifier:
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954956
Page 126 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-07-2020
14:19:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954957
Page 127 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954958
Page 128 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
5. Specimen Type:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifie
r:Not Ap
plicable
Test:: Not Ap
plicable
Result:: Not Ap
plicable
Not Done:: Not Ap
plicableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954959
Page 129 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
6.a Test:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-07-2020
14:19:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954960
Page 130 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-07-2020
14:20:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-07-2020
14:20:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
223894Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954961
Page 131 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020
14:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020
14:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020
14:21:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-07-2020
14:20:54
(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.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954962
Page 132 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-07-2020
14:20:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-13-2020
21:27:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Aug-12-2020
09:12:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Changed data
per query
Aug-11-2020
06:12:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened Subject is listed
to have:2 serum
samples, which
is less than the 5
expected. Please
review and
update Q4 as
appropriate, else
clarify.
5.a
Date Location User Value Reason
Aug-07-2020
14:21:56
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Sample ID
:BMPYH
DInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0954963
Page 133 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
5.a Sample ID
Date Location User Value Reason
Aug-07-2020
14:21:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BMPYHDInitial Entry
5.b
Date Location User Value Reason
Aug-07-2020
14:22:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMPYHFInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-07-2020
14:22:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BMPYHFInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020
09:12:22ACV0PFEINFP6000 Data Entry:
Sample ID: BNBCJPInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954964
Page 134 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00) Eastern
Time (US & Canada)
5.c Sample ID
Date Location User Value Reason
Aug-12-2020
09:12:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNBCJPInitial Entry
5.d
Date Location User Value Reason
Aug-12-2020
09:12:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNBCJRInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-12-2020
09:12:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNBCJRInitial Entry
5.e
Date Location User Value Reason
Aug-12-2020
09:12:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNBCJSInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0954965
Page 135 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.e Sample ID
Date Location User Value Reason
Aug-12-2020
09:12:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNBCJSInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954966
Page 136 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020
14:22:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020
14:22:33
(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-07-2020
14:23:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-07-2020
14:22:33
(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.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954967
Page 137 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-07-2020
14:22:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-07-2020
14:23:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNBCJ5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020
14:23:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNBCJ5Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954968
Page 138 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-07-2020
14:29:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-07-2020
14:29:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-07-2020
14:29:30
(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-07-2020
14:29:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/7/2020 10:48Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954969
Page 139 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5. Anatomical Location:
Date Location User Value Reason
Aug-07-2020
14:29:30
(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-07-2020
14:29:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-07-2020
14:29:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-07-2020
14:29:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954970
Page 140 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-07-2020
14:29:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954971
Page 141 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-07-2020
14:29:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENI
CITY E-DIARY COLL
ECTED FOR THIS SU
BJECTInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954972
Page 142 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020
20:18:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954973
Page 143 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954974
Page 144 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954975
Page 145 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.b Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954976
Page 146 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.c Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954977
Page 147 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.d Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954978
Page 148 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.e Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954979
Page 149 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.f Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954980
Page 150 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.g Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED JInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954981
Page 151 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?:NO
2.h Symptom:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D 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
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954982
Page 152 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4. Injection Site Body Side:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was complet
ed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
20:24:37
(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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954983
Page 153 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954984
Page 154 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITE
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954985
Page 155 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020
20:24:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954986
Page 156 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020
20:25:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020
20:25:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Iden
tifier::1
Temperature
:97.4
Temperature
Unit:F
Temperature
Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020
20:25:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954987
Page 157 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-31-2020
20:25:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020
20:25:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-31-2020
20:25:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954988
Page 158 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954989
Page 159 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Def
ined Identifi
er:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954990
Page 160 of 209
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
6.a Test:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-31-2020
20:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954991
Page 161 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020
20:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020
20:25:32
(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-31-2020
20:25:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-31-2020
20:25:32
(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.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0954992
Page 162 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-31-2020
20:25:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020
20:25:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPXVM
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020
20:25:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPXVMFInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954993
Page 163 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020
20:26:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020
20:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020
20:26:19
(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-31-2020
20:26:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 09:27Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954994
Page 164 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020
20:26:19
(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-31-2020
20:26:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020
20:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020
20:26:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIF
IED OBSERVATION PERI
ODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954995
Page 165 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-31-2020
20:26:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0954996
Page 166 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020
16:18:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954997
Page 167 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
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
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954998
Page 168 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:N
OInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0954999
Page 169 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.b Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-29-2020
16:18:58
(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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955000
Page 170 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.c Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:N
OInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955001
Page 171 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.d Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955002
Page 172 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.e Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-29-2020
16:18:58
(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 compl
eted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955003
Page 173 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.f Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PAI
N
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955004
Page 174 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.g Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D 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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAIN
Were fever or
systemic symp
toms present
on the last da
y the Subject
Diary was co
mpleted?:NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955005
Page 175 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.h Symptom:
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D 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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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
Oct-23-2020
13:57:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955006
Page 176 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-23-2020
09:19:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-23-2020
09:19:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
Oct-23-2020
09:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-22-2020
19:23:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Steven Finegan
ProdQuery 1: Opened V2 vaccination
body side is
reported as
"LEFT" while
V3 Injection
site body side is
reported as "Not
Applicable".
Please review
and update as
appropriate.
Sep-29-2020
16:19:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955007
Page 177 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection sit
e reactions prese
nt on the last day
the Subject Diary
was completed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::SW
ELInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955008
Page 178 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)LIN
G
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020
16:18:58
(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-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJEC
TIONInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955009
Page 179 of 209
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
SITE
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020
16:18:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955010
Page 180 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020
16:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020
16:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020
16:27:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020
16:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPB0P7Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955011
Page 181 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-29-2020
16:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPB0P7Initial Entry
5.b
Date Location User Value Reason
Sep-29-2020
16:26:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLG0S6Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020
16:26:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLG0S6Initial Entry
5.c
Date Location User Value Reason
Sep-29-2020
16:27:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLG0RPInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955012
Page 182 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Sep-29-2020
16:27:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLG0RPInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955013
Page 183 of 209
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-22-2021
18:04:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955014
Page 184 of 209
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-22-2021
18:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-22-2021
18:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021
18:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-22-2021
18:04:56
(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.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955015
Page 185 of 209
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-22-2021
18:04:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/19/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021
18:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS236DInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-22-2021
18:05:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS236DInitial Entry
5.b
Date Location User Value Reason
Feb-22-2021
18:05:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRN1G
RInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955016
Page 186 of 209
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.b Sample ID
Date Location User Value Reason
Feb-22-2021
18:05:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRN1GRInitial Entry
5.c
Date Location User Value Reason
Feb-22-2021
18:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS236NInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-22-2021
18:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS236NInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955017
Page 187 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-29-2020
16:32:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-29-2020
16:32:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-29-2020
16:32:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955018
Page 188 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Feb-23-2021
15:12:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955019
Page 189 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Feb-23-2021
15:12:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-23-2021
15:12:43
(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-08-2021
17:57:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 4: Closed no presenting
complaint
reported; closing
for data lock
Mar-04-2021
16:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 4: Answered Including this in
the SAE
submission today.
Mar-04-2021
12:55:22
(UTC-05:00)ACV0PFEINFP6000 Query 1: Closed SAE states TAH +
BSO on
09Feb2021
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955020
Page 190 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
Mar-04-2021
12:53:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 5: Closed Query closed; will
follow for
requested uterine
CA
histopathologic
information.
Mar-04-2021
12:53:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 4: Reissued:Op
enedClinical - due to
data lock, please
submit Subject's
report as to how
she came to
schedule surgery
on Jan 25, 2021
Mar-04-2021
12:50:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-04-2021
12:50:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-24-2021
17:55:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Sent a follow-up
SAE
Feb-24-2021
17:55:03
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 4: Answered Waiting on
Medical Records.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955021
Page 191 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada)
Feb-24-2021
17:54:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered Sent a follow-up
SAE
Feb-24-2021
17:53:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Sent a Follow-up
SAE
Feb-24-2021
17:53:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 5: Answered Waiting on
Medical records.
Feb-23-2021
18:55:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 5: Opened Clinical Please
submit tumor
stage and
histopathological
results in a SAE
safety update
Feb-23-2021
18:42:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 4: Opened Clinical Please
submit a SAE
update with the
clinical course
which led to
Uterine CA
diagnosis (signs
or symptoms,
exam, diagnostic
imaging, etc)
Feb-23-2021
18:39:29ACV0PFEINFP6000 Query 3: Opened Clinical Please
submit any
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955022
Page 192 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time (US
& Canada)medications taken
for systemic
conditions (for
HTN, T2DM, etc)
to the SAE Com
Meds section
Feb-23-2021
18:38:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical SAE
report Med Hx
section says 'not
applicable';
however, for
surgical/radiation
subject with
malignancy,
systemic
conditions are
relevant. Please
submit to SAE
Med hx (HTN,
T2DM, other)
Feb-23-2021
18:35:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical SAE
report specifies
total Abd
Hysterectomy
performed on
08Feb21; please
submit
information to
SAE whether bilat
oophorectomy
was also
performed
(Yes/No)
Feb-23-2021
15:12:43
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Uterine CancerInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955023
Page 193 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)
4. Start Date Time:
Date Location User Value Reason
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-04-2021
12:47:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-24-2021
10:20:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955024
Page 194 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-24-2021
10:20:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
4Transcription
Error
Feb-23-2021
18:54:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Clinical -
Toxicity/severity
grade is 3;
however, serious
criteria include
Life-threatening
which is grade 4
(protocol Sect
10.3.3). Please
harmonize,
updating
whichever
parameter is
required, in both
AE/SAE report
Feb-23-2021
15:12:43
(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
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955025
Page 195 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-05-2021
20:44:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-04-2021
16:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered New Information
Mar-04-2021
16:06:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with cong
enital anomaly or bir
th defect?
NO
Did this serious even
t result in death?
NO
Did this serious even
t require or prolong h
ospitalization?
YES
Did this serious even
t result in persistent
or significant disabili
ty/incapacity?
NONew Information
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955026
Page 196 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Is this serious event l
ife threatening?
YES
Other medically imp
ortant serious event
NO
Mar-04-2021
12:50:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Query closed;
will follow for
requested COVID
test information.
Mar-04-2021
12:48:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Reissued:Op
enedClinical thank
you; Serious
criteria are now
HOSP and
Life-threatening
in SAE; however,
only Hosp here
on AE log. Please
harmonize
reporting /
update.
Feb-24-2021
17:55:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Answered Waiting on
Medical Records.
Feb-24-2021
17:53:24
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Query 2: Answered Submitted
Follow-Up SAE
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955027
Page 197 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
& Canada)
Feb-24-2021
03:38:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-23-2021
18:40:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021187485] to
document if
COVID testing
was performed
(YES/NO or info
not available) and
if yes, the date
and results.
Feb-23-2021
18:34:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Opened Clinical - serious
criteria do not
include
Hospitalization;
however, SAE
report states
subject was
hospitalized from
Feb 8-9, 2021 for
TAH surgery.
Please review,
and update
serious criteria as
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955028
Page 198 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
required in both
AE/SAE report.
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Uterine
Cancer: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is
blank.
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with cong
enital anomaly or bir
th defect?
NO
Did this serious even
t result in death?
NO
Did this serious even
t require or prolong h
ospitalization?
NO
Did this serious even
t result in persistent
or significant disabili
ty/incapacity?
NOInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955029
Page 199 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Is this serious event l
ife threatening?
YES
Other medically imp
ortant 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.
Date Location User Value Reason
Feb-23-2021
15:12:43
(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
Feb-23-2021
15:18:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study
treatment(s), this event
is due to:
OTHER
If Other, specify:
Unopposed ERTNew
Information
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955030
Page 200 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-23-2021
15:12:43
(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
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955031
Page 201 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Mar-09-2021
05:50:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed SDB updated
Mar-08-2021
02:06:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Cand
idatePending SDB
update
Mar-04-2021
16:18:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Submitted
today!
Mar-03-2021
15:43:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Reissued:Open
edSAE RECON1:
Thanks for the
response. Please
confirm
submission of
SAE follow up
form.
Mar-03-2021
09:17:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered This will be
submitted to
Safety.
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (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-2021-5683-0955032
Page 202 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-02-2021
02:59:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Open
edSAE RECON 1: outcome was
reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB. Please submit a follow
up form to update outcome in Safety
database to
RECOVERING/RESOLVING per
previous query response.
Mar-01-2021
16:44:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dSubject is still recovering from
cancer.
Feb-26-2021
00:23:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedSAE
RECON:AER#2021187485,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-23-2021
15:12:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
REC
OVE
RINGInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955033
Page 203 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
/RES
OLVI
NG
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-23-2021
15:12:43
(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
Feb-24-2021
03:38:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
2021187485Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955034
Page 204 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021
16:49:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955035
Page 205 of 209
***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
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-21-2021
16:49:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-21-2021
16:49:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP visit.
Please complete
this date.
Jan-21-2021
16:49:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955036
Page 206 of 209
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-21-2021
16:49:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-21-2021
16:49:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONA
L VACCINATIONInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955037
Page 207 of 209
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-29-2020
16:32:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-07-2020
14:20:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZ
EDInitial Entry
Aug-07-2020
14:13:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-23-2021
18:40:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Feb-23-2021
15:18:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-23-2021
09:23:01
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened CLINICAL SAE
report
(#2021187485)
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955038
Page 208 of 209
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US
& Canada)received for
event Uterine
Cancer; please
report this event
on the AE CRF
Sep-29-2020
16:32:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/29/2020Initial Entry
Aug-07-2020
14:20:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/7/2020Initial Entry
Aug-07-2020
14:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/7/2020Initial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955039
Page 209 of 209
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791076 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020
15:40:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f25\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955040