Document text
Page 1 of 171
***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: 10801035 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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956301
Page 2 of 171
***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: 10801035 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/14/2020
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956302
Page 3 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10801035]
2.Birth Date: /1946
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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956303
Page 4 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956304
Page 5 of 171
***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: 10801035 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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956305
Page 6 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956306
Page 7 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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:[Recurrent Depression]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroid]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post menopausal]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956307
Page 8 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [66.2]
3.Unit: kg
4.Height: [168.5]
5.Unit: cm
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956308
Page 9 of 171
***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: 10801035 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/14/2020
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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956309
Page 10 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [228121]
3.Randomization Group: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956310
Page 11 of 171
***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: 10801035 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/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP59Y2]
5.bSample ID [BP59Y3]
5.cSample ID [BP59Y4]
5.dSample ID [BPRN74]
5.eSample ID [BPRN75]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956311
Page 12 of 171
***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: 10801035 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/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP59H0]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956312
Page 13 of 171
***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: 10801035 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/14/2020 11:43
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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956313
Page 14 of 171
***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: 10801035 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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956314
Page 15 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956315
Page 16 of 171
***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: 10801035 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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956316
Page 17 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956317
Page 18 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956318
Page 19 of 171
***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: 10801035 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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956319
Page 20 of 171
***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: 10801035 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/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP59MZ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956320
Page 21 of 171
***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: 10801035 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/4/2020 11:21
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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956321
Page 22 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956322
Page 23 of 171
***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: 10801035 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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956323
Page 24 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956324
Page 25 of 171
***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: 10801035 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:
Oct/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTSMP]
5.bSample ID [BRT47H]
5.cSample ID [BRT47J]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956325
Page 26 of 171
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956326
Page 27 of 171
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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:
Feb/26/2021
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 [BR9RF3]
5.bSample ID [BRT41P]
5.cSample ID [BRT41N]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956327
Page 28 of 171
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956328
Page 29 of 171
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956329
Page 30 of 171
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956330
Page 31 of 171
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956331
Page 32 of 171
***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: 10801035 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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956332
Page 33 of 171
***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: 10801035 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: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956333
Page 34 of 171
***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: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956334
Page 35 of 171
***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: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956335
Page 36 of 171
***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: 10801035 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?
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956336
Page 37 of 171
***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: 10801035 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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956337
Page 38 of 171
***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: 10801035 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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956338
Page 39 of 171
***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: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956339
Page 40 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956340
Page 41 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956341
Page 42 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956342
Page 43 of 171
***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: 10801035 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: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956343
Page 44 of 171
***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: 10801035 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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956344
Page 45 of 171
***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: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956345
Page 46 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Stage 0 Breast Cancer R
ight Breast Oct/30/2020 UN
K:UNK NO
End Date Time:
Dec/3/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 Fatigue Jan/7/2021 UNK
:UNK YES Repeating
Pages
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956346
Page 47 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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)[Stage 0 Breast Cancer Right Breast]
4.Start Date Time: Oct/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/3/2020 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?
NO
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
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956347
Page 48 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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?NO
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[2021046445]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956348
Page 49 of 171
***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: 10801035 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)[Fatigue]
4.Start Date Time: Jan/7/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Due to radiation therapy, has improved since finishing Radiation]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956349
Page 50 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956350
Page 51 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956351
Page 52 of 171
***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: 10801035 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[ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956352
Page 53 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956353
Page 54 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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.Date: //
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956354
Page 55 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956355
Page 56 of 171
***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: 10801035 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?
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956356
Page 57 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956357
Page 58 of 171
***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: 10801035 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?
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956358
Page 59 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956359
Page 60 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956360
Page 61 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956361
Page 62 of 171
***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: 10801035 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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956362
Page 63 of 171
***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: 10801035 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:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956363
Page 64 of 171
***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: 10801035 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?
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956364
Page 65 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956365
Page 66 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956366
Page 67 of 171
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956367
Page 68 of 171
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956368
Page 69 of 171
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956369
Page 70 of 171
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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 [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956370
Page 71 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956371
Page 72 of 171
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956372
Page 73 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956373
Page 74 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956374
Page 75 of 171
***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: 10801035 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: [ ]
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956375
Page 76 of 171
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956376
Page 77 of 171
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956377
Page 78 of 171
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956378
Page 79 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-14-2020 17:16:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956379
Page 80 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956380
Page 81 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Sep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956381
Page 82 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Sep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956382
Page 83 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Sep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956383
Page 84 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Sep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956384
Page 85 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Sep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956385
Page 86 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956386
Page 87 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956387
Page 88 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-04-2020 21:38:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956388
Page 89 of 171
***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: 10801035 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-24-2021 08:54:17 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Jan-25-2021 16:41:30 (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 Jan-25-2021 05:24:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Jan-22-2021 10:02:57 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956389
Page 90 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 Jan-21-2021 15:43:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner Approved Oct-12-2020 16:31:59 (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.
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956390
Page 91 of 171
***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: 10801035 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-14-2020 17:15:04
(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-14-2020 17:15:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956391
Page 92 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 17:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/14/2020Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956392
Page 93 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 17:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10801035Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 17:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 17:16:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 17:16:34
(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-14-2020 17:16:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae40cf\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-2021-5683-0956393
Page 94 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-10-2020 02:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-09-2020 12:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Per PI, subject did
not require a
COVID Illness
visit.
Oct-03-2020 04:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
31AUG2020. But
there is no COVID
Illness visit
reported in the
database. Please
clarify.
Aug-14-2020 17:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956394
Page 95 of 171
***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: 10801035 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-14-2020 17:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 17:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 17:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956395
Page 96 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 17:22:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Recurrent Depr
ession
Start Date: UNK/UNK/19
95
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:22:23
(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-14-2020 17:22:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Recurrent DepressionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 17:22:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020 17:22:23
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40cf\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-2021-5683-0956396
Page 97 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
1.b
Date Location User Value Reason
Aug-14-2020 17:23:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hypothyroid
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956397
Page 98 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:23:00
(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-14-2020 17:23:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 17:23:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 17:23:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-14-2020 17:23:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Osteoporosis
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae40cf\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-2021-5683-0956398
Page 99 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:23:30
(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-14-2020 17:23:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OsteoporosisInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 17:23:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 17:23:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-14-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Post menopa
usal
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
090177e196ae40cf\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-2021-5683-0956399
Page 100 of 171
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:23:52
(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-14-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Post menopausalInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40cf\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-2021-5683-0956400
Page 101 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
66.2Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
168.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae40cf\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-2021-5683-0956401
Page 102 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.3Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 17:17:52
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae40cf\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-2021-5683-0956402
Page 103 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956403
Page 104 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020 17:18:55
(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-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-14-2020 17:18:55
(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-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956404
Page 105 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-14-2020 17:18:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956405
Page 106 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 17:19:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 17:19:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
228121Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956406
Page 107 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 17:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 17:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 18:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 17:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 17:19:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 18:41:34
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956407
Page 108 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) Sample ID: BP59Y2
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 18:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59Y2Initial Entry
5.b
Date Location User Value Reason
Aug-14-2020 18:41:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP59Y3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 18:41:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59Y3Initial Entry
5.c
Date Location User Value Reason
Aug-14-2020 18:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP59Y4Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 18:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59Y4Initial Entry
5.d
Date Location User Value Reason
090177e196ae40cf\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-2021-5683-0956408
Page 109 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-14-2020 18:42:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRN74Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 18:42:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRN74Initial Entry
5.e
Date Location User Value Reason
Aug-24-2020 09:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRN75Transcription Error
(DELETED)
Aug-14-2020 18:42:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRN75Initial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956409
Page 110 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.e Sample ID
Date Location User ValueReason
Aug-25-2020
05:31:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Aug-24-2020
09:04:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
BPR
N75Transcription Error
(DELETED)
Aug-24-2020
09:04:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Aug-24-2020
03:43:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM 2: Thanks for
the response, form
has been unfreeze,
Please update the
form as per below
query.
Aug-21-2020
09:31:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dUnfreeze so I can
delete it
Aug-20-2020
11:05:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM 1: Thanks for
the response,
Kindly update the
correct barcode for
the subject
accordingly.
090177e196ae40cf\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-2021-5683-0956410
Page 111 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-20-2020
09:33:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dThis is for subject
10801036 and
needs to be deleted.
Aug-20-2020
05:43:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW4238465;The
barcode BPRN75
is recorded for two
subjects 10801035
and 10801036,
Please review and
update as
appropriate.
Aug-14-2020
18:42:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
BPR
N75Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956411
Page 112 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 17:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 17:19:46
(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-14-2020 18:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 17:19:46
(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-14-2020 17:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 18:42:59
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Transcription Error
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956412
Page 113 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) Sample ID: BP59H0
Aug-14-2020 18:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5H0Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 18:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 18:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59H0Transcription Error
Aug-14-2020 18:42:40
(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-14-2020 18:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5H0Initial Entry
090177e196ae40cf\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-2021-5683-0956413
Page 114 of 171
***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: 10801035 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-14-2020 17:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 17:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 17:20:24
(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-14-2020 17:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020 11:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 17:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956414
Page 115 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-14-2020 17:20:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-14-2020 17:20:24
(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-14-2020 17:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-14-2020 17:20:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956415
Page 116 of 171
***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: 10801035 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-14-2020 17:20:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956416
Page 117 of 171
***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: 10801035 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-04-2020 21:38:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956417
Page 118 of 171
***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: 10801035 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 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-11-2020 15:17:25 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae40cf\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-2021-5683-0956418
Page 119 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)Symptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956419
Page 120 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.c Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956420
Page 121 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.e
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956421
Page 122 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae40cf\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-2021-5683-0956422
Page 123 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae40cf\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-2021-5683-0956423
Page 124 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.h Symptom:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ES
S
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956424
Page 125 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956425
Page 126 of 171
***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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN A
T INJE
CTION
SITE
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-11-2020 15:17:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956426
Page 127 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 21:38:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 21:38:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.6
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 21:38:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020 21:38:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020 21:38:32
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae40cf\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-2021-5683-0956427
Page 128 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 21:38:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956428
Page 129 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae40cf\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-2021-5683-0956429
Page 130 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-04-2020 21:38:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae40cf\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-2021-5683-0956430
Page 131 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 21:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 21:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 21:39:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 21:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 21:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 21:39:39
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956431
Page 132 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) Sample ID: BP59MZ
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 21:39:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP59MZInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0956432
Page 133 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 11:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956433
Page 134 of 171
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020 21:40:05
(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
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 21:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956434
Page 135 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-02-2020 17:20:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956435
Page 136 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(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
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-07-2020 17:14:58 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae40cf\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-2021-5683-0956436
Page 137 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)Symptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956437
Page 138 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.c Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956438
Page 139 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.e
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956439
Page 140 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.f Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae40cf\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-2021-5683-0956440
Page 141 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.g Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae40cf\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-2021-5683-0956441
Page 142 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.h Symptom:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ES
S
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956442
Page 143 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956443
Page 144 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN A
T INJE
CTION
SITE
Were injection site r
eactions present on t
he last day the Subje
ct Diary was complet
ed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 17:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956444
Page 145 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 17:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 17:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 17:12:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-03-2020 06:19:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 17:20:25
(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.
Oct-02-2020 17:20:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956445
Page 146 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Oct-07-2020 17:12:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPTSMPInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 17:12:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPTSMPInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 17:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRT47HInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 17:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRT47HInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 17:13:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRT47JInitial Entry
090177e196ae40cf\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-2021-5683-0956446
Page 147 of 171
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 17:13:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRT47JInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956447
Page 148 of 171
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 11:24:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/26/2021Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956448
Page 149 of 171
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 11:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 11:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021 08:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 06:14:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 11:24:31
(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.
Feb-26-2021 11:24:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956449
Page 150 of 171
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Mar-01-2021 08:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
Sample ID: BR9RF3Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021 08:44:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
BR9RF3Initial Entry
5.b
Date Location User Value Reason
Mar-01-2021 08:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
Sample ID: BRT41PInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-01-2021 08:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
BRT41PInitial Entry
5.c
Date Location User Value Reason
Mar-01-2021 08:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
Sample ID: BRT41NInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956450
Page 151 of 171
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.c Sample ID
Date Location User Value Reason
Mar-01-2021 08:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
BRT41NInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956451
Page 152 of 171
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 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
Oct-02-2020 16:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 16:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 16:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956452
Page 153 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956453
Page 154 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956454
Page 155 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-28-2021 17:28:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for
requested surgical
pathology
information.
Jan-26-2021 16:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie Maples Query 2: Answered Updates will be
sent.
Jan-26-2021 00:28:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-25-2021 14:14:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie Maples Query 1: Answered Will update and
submit SAE.
Jan-25-2021 10:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL Please
submit a SAE
safety update with
the results of the
surgical pathology
report, if available.
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956455
Page 156 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Jan-25-2021 10:21:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - Event
term Stage 0 breast
CA includes Rt
side; however,
SAE term does not
include any side.
Please submit a
SAE update to
include the side of
the lesion.
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Stage 0 Breast Cancer Right Br
eastInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/30/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-28-2021 17:27:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 12:30:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie Maples Query 1: Answered SAE will be
updated with end
date.
Jan-25-2021 10:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical End date
is 03Dec20;
however, SAE
report has no end
date for the serious
event. Please
submit a SAE
safety update with
the SAE event end
date.
090177e196ae40cf\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)
(b) (4)
FDA-CBER-2021-5683-0956456
Page 157 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/3/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-25-2021 05:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Stage 0
Breast Cancer
Right Breast:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NOInitial Entry
090177e196ae40cf\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-2021-5683-0956457
Page 158 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous 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.
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHERInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956458
Page 159 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
If Other, specify:
Unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-26-2021 00:30:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed erro
Jan-26-2021 00:29:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Non-drug
treatment for SAE
is NO; however,
SAE report states
subject underwent
lumpectomy on
03Dec20, followed
by radiation. Please
review non-drug
treatment, and
update if
appropriate
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae40cf\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-2021-5683-0956459
Page 160 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-21-2021 15:43:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-25-2021 05:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021046445Initial Entry
090177e196ae40cf\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-2021-5683-0956460
Page 161 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021 01:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Mar-01-2021 12:30:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesQuery 1: Answered Patient was
vaccinated in
August/September of
2020. Patient
underwent radiation
therapy in January
2021 after
lumpectomy for
stage 0 breast cancer
which is the reason
for her fatigue.
Radiation has ended
so she is steadily
improving.
Mar-01-2021 08:56:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Since
FATIGUE is one of
the CDC-defined
symptoms of
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956461
Page 162 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
COVID-19 (protocol
section 8.1), please
consider whether
this symptom, could
have been due to
COVID-19 and
should have
triggered a potential
COVID-19 illness
visit
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956462
Page 163 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Due to radiation therapy, h
as improved since finishin
g RadiationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956463
Page 164 of 171
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-26-2021 15:11:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae40cf\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)
FDA-CBER-2021-5683-0956464
Page 165 of 171
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 09:06:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
Jan/19/2021Transcription Error
Feb-24-2021 08:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
Jan/20/2021Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956465
Page 166 of 171
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-26-2021 11:27:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Transcription Error
Feb-25-2021 09:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-25-2021 05:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-24-2021 08:55:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-24-2021 08:55:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie Maples Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956466
Page 167 of 171
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eligible per local/national r
ecommendations and confir
med to have received only
placebo at Vaccination 1/2
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956467
Page 168 of 171
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-25-2021 09:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
Feb/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-25-2021 09:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mollie
MaplesData Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956468
Page 169 of 171
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-02-2020 16:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020 17:19:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-14-2020 17:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-22-2021 11:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Jan-21-2021 15:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Added SAE
Jan-21-2021 05:31:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021046445
stage zero breast
cancer(onset
date:30Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-02-2020 16:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
090177e196ae40cf\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-2021-5683-0956469
Page 170 of 171
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research
of Cary
Subject No: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Aug-14-2020
17:19:20 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020
17:17:11 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956470
Page 171 of 171
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail 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: 10801035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-12-2020 16:21:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae40cf\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0956471