Document text
Page 1 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955921
Page 2 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955922
Page 3 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10801013]
2.Birth Date: /1942
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955923
Page 4 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955924
Page 5 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955925
Page 6 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955926
Page 7 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibromyalgia]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dry Eyes, Bilateral]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2012
Ongoing: YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955927
Page 8 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Upset Stomach]
Start Date: UNK/UNK/2012
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dermatographia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Torn Meniscus]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Inguinal Hernia]
Start Date: Jul/UNK/2006
Ongoing: YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955928
Page 9 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Knee Replacement, Left Leg]
Start Date: Jan/UNK/2011
Ongoing: NO
End Date:
Jan/UNK/2011
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955929
Page 10 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [66.5]
3.Unit: kg
4.Height: [156.5]
5.Unit: cm
6.Body Mass Index: [27.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955930
Page 11 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955931
Page 12 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225859]
3.Randomization Group: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955932
Page 13 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
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 [BP59VY]
5.bSample ID [BP59VZ]
5.cSample ID [BP59W0]
5.dSample ID [BPRN5X]
5.eSample ID [BPRN5Y]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955933
Page 14 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
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 [BP59FW]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955934
Page 15 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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/11/2020 13:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955935
Page 16 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955936
Page 17 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955937
Page 18 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?YES
Ongoing?
NO
Stop Date:
Sep/1/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955938
Page 19 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
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
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955939
Page 20 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955940
Page 21 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955941
Page 22 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP59LF]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955942
Page 23 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/1/2020 12:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955943
Page 24 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955944
Page 25 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955945
Page 26 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955946
Page 27 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
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 [BPTSPS]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955947
Page 28 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955948
Page 29 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955949
Page 30 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955950
Page 31 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955951
Page 32 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955952
Page 33 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955953
Page 34 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955954
Page 35 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955955
Page 36 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955956
Page 37 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955957
Page 38 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955958
Page 39 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955959
Page 40 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955960
Page 41 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955961
Page 42 of 380
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Osteoarthritis of the
knee Oct/26/2020 UNK:
UNK NO
End Date Time:
Oct/26/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Perforated Colon Oct/31/2020 UNK:
UNK YES Repeating
Pages
3.ADVERSE EV
ENT 3 Ischemic colitis Oct/31/2020 UNK:
UNK YES Repeating
Pages
4.ADVERSE EV
ENT 4 Constipation Oct/31/2020 UNK:
UNK YES Repeating
Pages
5.ADVERSE EV
ENT 5 Atrial Fibrillation Nov/11/2020 UNK:
UNK YES Repeating
Pages
6.ADVERSE EV
ENT 6 Diuresis Nov/9/2020 UNK:
UNK YES Repeating
Pages
7.ADVERSE EV
ENT 7 Acute parotitis Nov/8/2020 UNK:
UNK YES Repeating
Pages
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955962
Page 43 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Osteoarthritis of the knee]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955963
Page 44 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Osteoarthritis of the knee which led to knee replacement]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020443255]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955964
Page 45 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Perforated Colon]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955965
Page 46 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Constipation]Comments
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[2020443355]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955966
Page 47 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Ischemic colitis]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955967
Page 48 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Constipation]
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[2020443355]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955968
Page 49 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Constipation]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955969
Page 50 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020443355]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955970
Page 51 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Atrial Fibrillation]
4.Start Date Time: Nov/11/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955971
Page 52 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955972
Page 53 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diuresis]
4.Start Date Time: Nov/9/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955973
Page 54 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955974
Page 55 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute parotitis]
4.Start Date Time: Nov/8/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955975
Page 56 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955976
Page 57 of 380
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955977
Page 58 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955978
Page 59 of 380
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart Dat
eForm Instan
ce
1. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
2. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
3. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
4. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
5. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
6. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
7. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
8. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
9. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
10. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
11. DELETED Not Applicable Not Applicable Not Applicable Not Applicab
le Not Appli
cable Repeating
Pages
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955979
Page 60 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955980
Page 61 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955981
Page 62 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955982
Page 63 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955983
Page 64 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955984
Page 65 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955985
Page 66 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955986
Page 67 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955987
Page 68 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955988
Page 69 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955989
Page 70 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955990
Page 71 of 380
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955991
Page 72 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955992
Page 73 of 380
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0955993
Page 74 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
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(b) (4)
FDA-CBER-2021-5683-0955994
Page 75 of 380
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955995
Page 76 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955996
Page 77 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955997
Page 78 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955998
Page 79 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955999
Page 80 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956000
Page 81 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956001
Page 82 of 380
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956002
Page 83 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956003
Page 84 of 380
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956004
Page 85 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956005
Page 86 of 380
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956006
Page 87 of 380
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956007
Page 88 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956008
Page 89 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/14/2021
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956009
Page 90 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956010
Page 91 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956011
Page 92 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/14/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956012
Page 93 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BPTSCX]
5.bSample ID [BRT3TN]
5.cSample ID [BRT3TR]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956013
Page 94 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BPTS5N]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956014
Page 95 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/14/2021 13:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956015
Page 96 of 380
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956016
Page 97 of 380
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/4/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956017
Page 98 of 380
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BR9R9M]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956018
Page 99 of 380
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 12:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956019
Page 100 of 380
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956020
Page 101 of 380
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/4/2021
3.Comments: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956021
Page 102 of 380
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956022
Page 103 of 380
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956023
Page 104 of 380
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956024
Page 105 of 380
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956025
Page 106 of 380
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Mar/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956026
Page 107 of 380
***Confidential***
Header Text: c4591001
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Subject No: 10801013 Subject Initials: ---
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Subject No: 10801013 Subject Initials: ---
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Subject No: 10801013 Subject Initials: ---
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Subject No: 10801013 Subject Initials: ---
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Subject No: 10801013 Subject Initials: ---
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Cary
Subject No: 10801013 Subject Initials: ---
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Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
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Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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9Nov-13-2020 12:28:31 (UTC-05:00) Eastern
Time (US & Canada)A confirmed possible etiology will be entered
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Cary
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090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956089
Page 170 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Aug-12-2020 13:04:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956090
Page 171 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Aug-12-2020 13:04:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956091
Page 172 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Aug-12-2020 13:04:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956092
Page 173 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Aug-12-2020 13:04:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956093
Page 174 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Aug-12-2020 13:04:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956094
Page 175 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormAug-12-2020 13:05:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956095
Page 176 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Aug-12-2020 13:05:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956096
Page 177 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Aug-12-2020 13:05:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956097
Page 178 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Aug-12-2020 13:05:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956098
Page 179 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Aug-12-2020 13:05:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956099
Page 180 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Aug-12-2020 13:05:16 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956100
Page 181 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormAug-12-2020 13:05:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956101
Page 182 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Aug-12-2020 13:05:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956102
Page 183 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Aug-12-2020 13:05:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956103
Page 184 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Aug-12-2020 13:05:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956104
Page 185 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Aug-12-2020 13:05:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956105
Page 186 of 380
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Aug-12-2020 13:05:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956106
Page 187 of 380
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormJan-21-2021 14:47:18 (UTC-05:00) Eastern
Time (US & Canada)Mollie Maples Not Applicable
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956107
Page 188 of 380
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
Mollie Maples N/A Feb-04-2021 13:03:09 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Jan-21-2021 16:32:40 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-20-2020 11:21:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Nov-16-2020 17:36:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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.
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956108
Page 189 of 380
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
N/A Nov-10-2020 12:10:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Oct-12-2020 12:51:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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-30-2020 17:04:49 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Sep-18-2020 17:02:58 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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.
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956109
Page 190 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-11-2020 17:48:53
(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-11-2020 17:48:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956110
Page 191 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020 17:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/11/2020Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956111
Page 192 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020 17:48:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10801013Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020 17:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1942Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020 17:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-11-2020 17:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020 17:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956112
Page 193 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-11-2020 17:49:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956113
Page 194 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-11-2020 17:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020 17:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020 17:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956114
Page 195 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Aug-11-2020 17:50:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Fibromyalgia
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:50:55
(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-13-2020 06:30:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Aug-12-2020 16:30:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Condition is Stable
Aug-12-2020 14:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened GPD Clin: Per IC3
and Criteria for
Temporary Delay of
Enrolment (Protocol
5.5), please confirm
stability of
symptoms within 6
weeks of enrolment
and no acute event
within 48h before
study intervention
administration
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956115
Page 196 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-11-2020 17:50:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FibromyalgiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-11-2020 17:50:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020 17:50:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-11-2020 17:51:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:Hypertension
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956116
Page 197 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.b Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:51:27
(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-11-2020 17:51:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-11-2020 17:51:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-11-2020 17:51:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-11-2020 17:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Dry Eyes, Bila
teral
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956117
Page 198 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.c Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:52:28
(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-11-2020 17:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dry Eyes, BilateralInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-11-2020 17:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-11-2020 17:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-11-2020 18:05:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Insomnia
Start Date: UNK/UNK/2
012
Ongoing: YESInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956118
Page 199 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.d Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:05:35
(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-11-2020 18:05:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
InsomniaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-11-2020 18:05:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-11-2020 18:05:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-11-2020 18:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Upset Stomac
h
Start Date: UNK/UNK/2
012
Ongoing: YESInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956119
Page 200 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.e Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:06:04
(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-11-2020 18:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Upset StomachInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-11-2020 18:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-11-2020 18:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-11-2020 18:06:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Dermatograph
ia
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956120
Page 201 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.f Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:06:36
(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-11-2020 18:06:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DermatographiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-11-2020 18:06:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-11-2020 18:06:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-11-2020 18:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Torn Meniscus
Start Date: UNK/UNK/200
5Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956121
Page 202 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/
2005
1.g Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:07:19
(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-11-2020 18:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Torn MeniscusInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-11-2020 18:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-11-2020 18:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.h
Date Location User Value Reason
Aug-11-2020 18:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956122
Page 203 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Medical History
Term:Bilateral Inguinal
Hernia
Start Date: Jul/UNK/2006
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:08:00
(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-11-2020 18:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral Inguinal HerniaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-11-2020 18:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2006Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-11-2020 18:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-11-2020 18:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Histo
ry Term:Knee Replacement
, Left Leg
Start Date: Jan/UNK/2011Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956123
Page 204 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
Jan/UNK/2011
1.i Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-21-2020 16:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Nov-20-2020 15:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Completed as
requested
Nov-19-2020 14:32:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - SAE
medical history now
includes the
underlying
condition of OA;
however, it does not
appear on the Med
Hx CRF. Please
review for clinical
relevance to safety
event and update
Med Hx log CRF if
appropriate.
Nov-16-2020 14:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-16-2020 14:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956124
Page 205 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-16-2020 13:30:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Site does not have
OA reported on the
patient's medical
history. Will update
once medical
records are received
documenting a
medical history if
OA.
Nov-16-2020 13:26:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical - Please
note that OA is
already reported on
the SAE report;
please harmonize
the reporting of this
condition by also
documenting OA on
the Med Hx CRF
Nov-16-2020 12:59:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Will update once
medical records are
recieved and more
information is
avaliable.
Nov-16-2020 12:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Will update once
medical records are
recieved and more
information is
avaliable.
Nov-14-2020 18:06:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL -
Subject has past
Med Hx of Left
TKR. Please clarify
if SAE
(#202043255) is
now Right TKR, or
revision of Left
TKR, and update
with a SAE safety
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956125
Page 206 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
update
Nov-14-2020 18:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL -
Subject has SAE for
TKR for the
condition
Osteoarthritis of the
knee; however, Med
history on CRF and
SAE do not include
this condition.
Meniscal tear is
documented. Please
clarify condition and
update Med Hx
CRF, and SAE if
required.
Aug-11-2020 18:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Knee Replacement, Left LegInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-11-2020 18:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2011Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-11-2020 18:09:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/UNK/2011Initial Entry
1.j
Date Location User Value Reason
Nov-23-2020 09:13:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number
:10Transcription Error
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956126
Page 207 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Medical History T
erm:Osteoarthritis
Start Date: UNK/UNK/2
020
Ongoing: YES
Nov-20-2020 15:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:Osteoarthritis
Start Date: UNK/UNK/2
020
Ongoing: NO
End Date:
Oct/26/20
20Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956127
Page 208 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.j Line/MH Number:
Date Location User Value Reason
Nov-20-2020 15:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-20-2020 15:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OsteoarthritisInitial Entry
1.j Start Date:
Date Location User Value Reason
Dec-06-2020 11:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Acceptable
response
Dec-02-2020 16:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered We do not have a
start date for OA. It
was prior to study,
but we are not sure
when it actually
began.
Dec-01-2020 19:29:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Start
date of medical
history of OA
would precede the
first (Lt) total knee
replacement in
2011, if subject's
Med Hx is that
TKR was also for
OA. Start date of
Med Hx cannot be
after Day 1 (it
would be AE)
Nov-22-2020 23:20:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956128
Page 209 of 380
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-20-2020 15:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered The start date is
unknown.
Nov-20-2020 15:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
11/Aug/2020.
Please review and
update as
appropriate.
Nov-20-2020 15:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.j Ongoing:
Date Location User Value Reason
Nov-23-2020 09:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-23-2020 09:13:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-23-2020 09:13:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Nov-23-2020 08:10:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened CLINQUERY: If the
knee replacement
reported within the
AE listing was not a
planned procedure
from MH, then
please leave this
event of OA ongoing
at V1. Else, clarify
Nov-20-2020 15:27:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/26/2020Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956129
Page 210 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
66.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
156.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.2Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956130
Page 211 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020 18:11:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956131
Page 212 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956132
Page 213 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-12-2020 09:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Closed Query N/A due to
age
Aug-12-2020 06:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley
WyperQuery 1: Opened GPD Clin: Please
confirm why a
pregnancy test was
not done. There is
nothing in her
medical history to
indicate she is not a
woman of child
bearing potential.
Please update
MedHx as
appropriate.
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956133
Page 214 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-11-2020 18:14:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956134
Page 215 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020 18:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020 18:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
225859Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956135
Page 216 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 18:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 18:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 08:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 07:57:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query:
Response for
'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Thank you.
Aug-11-2020 18:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-11-2020 18:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956136
Page 217 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug/11/2020
5.a
Date Location User Value Reason
Aug-13-2020 08:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP59VYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 08:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59VYInitial Entry
5.b
Date Location User Value Reason
Aug-13-2020 08:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP59VZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 08:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59VZInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020 08:13:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP59W0Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956137
Page 218 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 08:13:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59W0Initial Entry
5.d
Date Location User Value Reason
Aug-13-2020 08:14:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRN5XTranscription Error
Aug-13-2020 08:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRN5XInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956138
Page 219 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 08:14:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-13-2020 08:14:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 08:14:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRN5XTranscription Error
Aug-13-2020 08:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text or
between words.
Please correct by
removing all data in
the field and
re-enter without
adding extra spaces
or using enter or tab
keys.
Aug-13-2020 08:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Aug-13-2020 08:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRN5XInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020 08:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRN5YInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956139
Page 220 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 08:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRN5YInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956140
Page 221 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 18:15:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 18:15:25
(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-11-2020 18:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 18:15:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-11-2020 18:15:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 18:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP59FWInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956141
Page 222 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Aug-11-2020 18:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59FWInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956142
Page 223 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-11-2020 18:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020 18:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020 18:16:25
(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-11-2020 18:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020 13:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020 18:16:25
(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-11-2020 18:16:25
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956143
Page 224 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-11-2020 18:16:25
(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-11-2020 18:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-11-2020 18:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956144
Page 225 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-11-2020 18:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956145
Page 226 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 15:27:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956146
Page 227 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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-11-2020 12:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-11-2020 12:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-11-2020 12:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 12:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-17-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATIGU
EInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956147
Page 228 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:YES
Ongoin
g?
NO
Stop
Date
:
Se
p/1
/20
20
Sep-15-2020 17:02:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Transcription Error
Sep-15-2020 16:55:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FATIGUE
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:YES
Ongoing
?
NO
Stop
Date:
UN
K/U
NK/
202
0Transcription Error
Sep-11-2020 12:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956148
Page 229 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956149
Page 230 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.b Symptom:
Date Location User Value Reason
Sep-11-2020 12:07:19
(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-18-2020 04:33:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-17-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Sep-17-2020 09:42:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/1/2020Initial Entry
Sep-16-2020 10:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM 2: Thanks for
your response.
Please verify and
update data for
Fatigue as it is
reported on Last
day (Day 7) in
e-diary. Thank you.
Sep-15-2020 17:02:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-15-2020 16:55:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
090177e196ae40ce\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956150
Page 231 of 380
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801013 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-15-2020 16:55:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
UNK/UNK/2020Transcription Error
Sep-15-2020 03:12:31
(UTC-05:00) Eastern
…[truncated]