125742 S1 M5 CRF c4591001 1011 10111181

Document text

Page 1 of 149
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135026
Page 2 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/8/2020
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135027
Page 3 of 149
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10111181]
2.Birth Date: 1963
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:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135028
Page 4 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135029
Page 5 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135030
Page 6 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135031
Page 7 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135032
Page 8 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135033
Page 9 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
2.Weight: [188.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [32.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135034
Page 10 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135035
Page 11 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/8/2020
2.Randomization Number: [267968]
3.Randomization Group: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135036
Page 12 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BR2VCZ]
5.bSample ID [BR2VD0]
5.cSample ID [BR2VCY]
5.dSample ID [BL9N3Y]
5.eSample ID [BL9N3Z]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135037
Page 13 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP9SYM]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135038
Page 14 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: Oct/8/2020 14:40
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
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135039
Page 15 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135040
Page 16 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135041
Page 17 of 149
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135042
Page 18 of 149
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/29/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135043
Page 19 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR2VM0]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135044
Page 20 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135045
Page 21 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135046
Page 22 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGCLW]
5.bSample ID [BRGCLY]
5.cSample ID [BRGCLX]
5.dSample ID [BGVV28]
5.eSample ID [BGVV29]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135047
Page 23 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135048
Page 24 of 149
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135049
Page 25 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135050
Page 26 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135051
Page 27 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135052
Page 28 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135053
Page 29 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135054
Page 30 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135055
Page 31 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135056
Page 32 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135057
Page 33 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135058
Page 34 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135059
Page 35 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135060
Page 36 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135061
Page 37 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135062
Page 38 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135063
Page 39 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135064
Page 40 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135065
Page 41 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Tingling around the
mouth Oct/8/2020 15:
15 NO
End Date Time:
Oct/8/2020 16:14
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Tingling at finger tip
s Oct/8/2020 15:
15 NO
End Date Time:
Oct/8/2020 16:15
 Repeating
Pages
 3.ADVERSE EV
ENT 3  Toothache  Oct/30/2020 0
9:00 NO
End Date Time:
Nov/17/2020 09:00
 Repeating
Pages
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135066
Page 42 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[Tingling around the mouth]
4.Start Date Time: Oct/8/2020 15:15
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/8/2020 16:14
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:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135067
Page 43 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12.Was a Non-Drug Treatment given? NO
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[ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135068
Page 44 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[Tingling at finger tips]
4.Start Date Time: Oct/8/2020 15:15
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/8/2020 16:15
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135069
Page 45 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
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[ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135070
Page 46 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Toothache]
4.Start Date Time: Oct/30/2020 09:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/17/2020 09:00
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:
[tooth ache]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135071
Page 47 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
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[ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135072
Page 48 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135073
Page 49 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135074
Page 50 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135075
Page 51 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: //
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135076
Page 52 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135077
Page 53 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135078
Page 54 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135079
Page 55 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135080
Page 56 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135081
Page 57 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135082
Page 58 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135083
Page 59 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135084
Page 60 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135085
Page 61 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135086
Page 62 of 149
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135087
Page 63 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135088
Page 64 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135089
Page 65 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135090
Page 66 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135091
Page 67 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135092
Page 68 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135093
Page 69 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135094
Page 70 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135095
Page 71 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135096
Page 72 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135097
Page 73 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135098
Page 74 of 149
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135099
Page 75 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/8/2020
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135100
Page 76 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135101
Page 77 of 149
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lauren
Calgreen Approved Feb-05-2021 09:39:15 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenCalgreen, 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.
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135102
Page 78 of 149
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-08-2020 16:12:43 (UTC-05:00) Eastern
Time (US & Canada)Linda Welch
(pfe.lwelch)Not Applicable
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135103
Page 79 of 149
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-08-2020 23:40:36 (UTC-05:00) Eastern
Time (US & Canada)Nancy Baker
(pfe.nbaker1)Not Applicable
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135104
Page 80 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135105
Page 81 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135106
Page 82 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135107
Page 83 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135108
Page 84 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135109
Page 85 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135110
Page 86 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135111
Page 87 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135112
Page 88 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135113
Page 89 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135114
Page 90 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
10Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135115
Page 91 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
11Oct-29-2020 17:52:10 (UTC-05:00) Eastern
Time (US & Canada)Rachel Pierce
(pfe.spierce)Not Done
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135116
Page 92 of 149
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lauren
Calgreen Approved Feb-05-2021 09:39:15 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenCalgreen, 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.
Linda Welch  N/A Feb-04-2021 16:46:47 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano  Approved Dec-03-2020 14:53:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch  N/A Dec-01-2020 13:05:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135117
Page 93 of 149
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Susann Varano  Approved Nov-12-2020 14:26:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Rachel Pierce  N/A Nov-11-2020 15:49:17 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano  Approved Nov-10-2020 12:05:08 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135118
Page 94 of 149
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-08-2020 16:11:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-08-2020 16:11:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135119
Page 95 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-08-2020 16:12:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/8/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135120
Page 96 of 149
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-08-2020 16:11:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10111181Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-08-2020 16:11:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1963Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-08-2020 16:12:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-08-2020 16:12:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-08-2020 16:12:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
WHITEInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135121
Page 97 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 16:12:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/8/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135122
Page 98 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-08-2020 16:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-08-2020 16:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-08-2020 16:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
COMPLETEDInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135123
Page 99 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-08-2020 23:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135124
Page 100 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
Oct/8/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
188.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.3Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135125
Page 101 of 149
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-08-2020 23:41:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
FOREHEADInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135126
Page 102 of 149
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
Oct/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135127
Page 103 of 149
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-08-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
NEGATIVEInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135128
Page 104 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-08-2020 23:41:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
Oct/8/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-08-2020 23:41:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
267968Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135129
Page 105 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 23:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 23:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 08:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-09-2020 03:19:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-08-2020 23:41:46
(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.
Oct-08-2020 23:41:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135130
Page 106 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Oct-09-2020 08:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BR2VCZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020 08:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
BR2VCZInitial Entry
5.b
Date Location User Value Reason
Oct-09-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BR2VD0Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
BR2VD0Initial Entry
5.c
Date Location User Value Reason
Oct-09-2020 08:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BR2VCYInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-09-2020 08:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
BR2VCYInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135131
Page 107 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d
Date Location User Value Reason
Oct-09-2020 08:47:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BL9N3YInitial Entry
5.d Sample ID
Date Location User ValueReason
Oct-12-2020
16:09:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Oct-12-2020
10:46:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Query
1: An
swere
dOriginal value is
correct
Oct-12-2020
07:44:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW4940192;The
Barcode BL9N3Y is
recorded for two
subjects 10111180
and 10111181. Please
review and update as
appropriate.
Oct-09-2020
08:47:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data
Entry
:
BL9N
3YInitial Entry
5.e
Date Location User Value Reason
Oct-09-2020 08:47:53
(UTC-05:00) EasternACV0PFEINFP6000  Linda
WelchData Entry:
Sample ID: BL9N3ZInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135132
Page 108 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.lwelch)
5.e Sample ID
Date Location User ValueReason
Oct-12-2020
16:09:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Oct-12-2020
10:46:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Query
1: An
swere
dOriginal value is
correct
Oct-12-2020
07:45:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW4940193;The
Barcode BL9N3Z is
recorded for two
subjects 10111180
and 10111181. Please
review and update as
appropriate.
Oct-09-2020
08:47:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data
Entry
:
BL9N
3ZInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135133
Page 109 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020 23:41:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020 23:41:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 12:58:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-09-2020 03:19:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-08-2020 23:41:59
(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-08-2020 23:41:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
YES
Date of Collection:
Oct/8/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135134
Page 110 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Oct-09-2020 12:58:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BP9SYMInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020 12:58:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Data Entry:
BP9SYMInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135135
Page 111 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020 23:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020 23:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020 23:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-08-2020 23:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
Oct/8/2020 14:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020 23:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020 23:42:10
(UTC-05:00) EasternACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
LEFTInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135136
Page 112 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-08-2020 23:42:10
(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
Oct-08-2020 23:42:10
(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
Oct-08-2020 23:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135137
Page 113 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-08-2020 23:42:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Nancy Baker
(pfe nbaker1)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135138
Page 114 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020 13:16:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/29/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135139
Page 115 of 149
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/29/2020Initial Entry
2.a
Date Location User Value Reason
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Record Identifier:: 1
Temperature: 96.5
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-29-2020 15:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jennifer
Mathias
(pfe mathij15)Query 1: Closed Response satisfies
query
Oct-29-2020 15:38:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Query 1: Answered Original value is
correct
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.5 F
is outside of
Normal Range 97 -
99.5 F.
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135140
Page 116 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data Entry:
96.5Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-29-2020 14:36:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
FOREHEADInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135141
Page 117 of 149
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135142
Page 118 of 149
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-29-2020 13:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NEGATIVEInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135143
Page 119 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 13:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 13:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 13:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 13:59:08
(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-29-2020 13:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020 13:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BR2VM0Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135144
Page 120 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 13:59:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gail Hopkins
(pfe.ghopkins)Data Entry:
BR2VM0Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135145
Page 121 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) EasternACV0PFEINFP6000  Rachel
PierceData Entry:
Not DoneInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135146
Page 122 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.spierce)
7. Route:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-29-2020 17:52:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Not DoneInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135147
Page 123 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-02-2020 13:27:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jennifer
Mathias
(pfe mathij15)Query 1: Closed Response satisfies
query
Dec-01-2020 15:26:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Query 1: Answered Added toothache to
AE
Dec-01-2020 15:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jennifer
Mathias
(pfe mathij15)Query 1: Opened Per source, subject
had toothache.
Please review and
add to AE CRF,
otherwise clarify.
Dec-01-2020 13:05:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data Entry:
Dec/1/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135148
Page 124 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-01-2020 13:28:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-01-2020 13:28:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-01-2020 13:28:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-01-2020 13:28:03
(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.
Dec-01-2020 13:28:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe hspain)Data Entry:
YES
Date of Collection:
Dec/1/2020Initial Entry
5.a
Date Location User Value Reason
Dec-01-2020 13:28:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
Sample ID: BRGCLWInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135149
Page 125 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Dec-01-2020 13:28:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
BRGCLWInitial Entry
5.b
Date Location User Value Reason
Dec-01-2020 13:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
Sample ID: BRGCLYInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-01-2020 13:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
BRGCLYInitial Entry
5.c
Date Location User Value Reason
Dec-01-2020 13:28:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
Sample ID: BRGCLXInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-01-2020 13:28:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
BRGCLXInitial Entry
5.d
Date Location User Value Reason
Dec-01-2020 13:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
Sample ID: BGVV28Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135150
Page 126 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Dec-01-2020 13:29:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
BGVV28Initial Entry
5.e
Date Location User Value Reason
Dec-01-2020 13:30:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
Sample ID: BGVV29Initial Entry
5.e Sample ID
Date Location User Value Reason
Dec-01-2020 13:30:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Holly
Spain
(pfe.hspain)Data Entry:
BGVV29Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135151
Page 127 of 149
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Form Created
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135152
Page 128 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Form Created
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135153
Page 129 of 149
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Form Created
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135154
Page 130 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-02-2020 09:46:20
(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
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Tingling around the mouthInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/8/2020 15:15Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date Time:
Oct/8/2020 16:14Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135155
Page 131 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)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
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)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
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020 10:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Query 2: Closed Response satisfies
query
Nov-11-2020 08:30:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Query 2: Answered This AE will stay,
will update the other
AE once unlocked.
Nov-10-2020 22:04:47 ACV0PFEINFP6000  Ute Frantz Query 2: Opened Only one primary
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135156
Page 132 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)(pfe.frantu) Adverse Event
should be chosen to
have question
'LATEST ACTION
TAKEN WITH
STUDY DRUG' that
would indicate
DRUG
WITHDRAWN.
Multiple are selected
at this time, please
select ONLY
Primary Adverse
Event.
Nov-10-2020 22:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe.frantu)Query 1: Closed issued in error
Nov-10-2020 21:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe.frantu)Query 1: Opened Only one primary
Adverse Event
should be chosen to
have question 'Did
the adverse event
cause the subject to
be discontinued
from the study?
answered as YES if
applicable. Please
chose Primary
Adverse Event.
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135157
Page 133 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-02-2020 09:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135158
Page 134 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-02-2020 09:54:33
(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
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Tingling at finger tipsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/8/2020 15:15Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date Time:
Oct/8/2020 16:15Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135159
Page 135 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)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
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)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
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 00:21:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 2: Closed Response satisfies
query
Nov-11-2020 15:49:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered changed information
due to Sponsor
instructions
Nov-11-2020 15:49:58 ACV0PFEINFP6000  Rachel Pierce Data Entry: changed information
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135160
Page 136 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)(pfe.spierce) NOT APPLICABLE due to Sponsor
instructions
Nov-11-2020 10:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Query 2: Reissued:Opened DM Q: Page is
unlocked and
unfrozen. Please
update.
Nov-11-2020 08:29:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Query 2: Answered page is locked,
unable to change
Nov-10-2020 22:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe frantu)Query 2: Opened Only one primary
Adverse Event
should be chosen to
have question
'LATEST ACTION
TAKEN WITH
STUDY DRUG' that
would indicate
DRUG
WITHDRAWN.
Multiple are selected
at this time, please
select ONLY
Primary Adverse
Event.
Nov-10-2020 22:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe frantu)Query 1: Closed issued in error
Nov-10-2020 21:12:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe frantu)Query 1: Opened Only one primary
Adverse Event
should be chosen to
have question 'Did
the adverse event
cause the subject to
be discontinued
from the study?
answered as YES if
applicable. Please
chose Primary
Adverse Event.
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data Entry:
DRUG WITHDRAWNInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135161
Page 137 of 149
***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, Locked, Frozen
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-02-2020 09:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135162
Page 138 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
ToothacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Oct/30/2020 09:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date Time:
Nov/17/2020 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135163
Page 139 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)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
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)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
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-04-2020 01:52:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Closed Response satisfies
query
Dec-03-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-03-2020 08:08:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:Transcription Error
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135164
Page 140 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
tooth ache
Dec-02-2020 11:41:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Opened GPDCLIN: Tooth
ache is listed as
related to study
Vaccine. Please
confirm causality
assessment and
clarify what
concomitant
treatment was
given.
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135165
Page 141 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-01-2020 15:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135166
Page 142 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 01:31:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe mahadp07)Query 1: Closed Closed as data
updated.
Nov-11-2020 15:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered date undated due to
Sponsor
instructions.
Nov-11-2020 15:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Data Entry:
Oct/8/2020date undated due to
Sponsor
instructions.
Nov-10-2020 21:18:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ute Frantz
(pfe frantu)Query 1: Opened The discontinuation
date of 29OCT2020
should be relative to
the AE causing the
the withdrawal of
the study vaccine,
AE start
08OCT2020 and
end 08OCT2020.
Please adjust
Discontinuation
date.
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135167
Page 143 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-02-2020 12:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jennifer
Mathias
(pfe mathij15)Query 3: Closed Response satisfies
query
Nov-02-2020 10:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda Welch
(pfe.lwelch)Query 3: Answered Changed data per
query
Oct-30-2020 13:43:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jennifer
Mathias
(pfe mathij15)Query 3: Reissued:Opened Please confirm as
no AE is entered.
Oct-30-2020 13:01:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Keri Clarke
(pfe.clarkek2)Query 2: Closed Response satisfies
query
Oct-30-2020 08:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Query 3: Answered entering now
Oct-30-2020 08:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from
the study' reported
as YES. Please
check and correct
the data.
Oct-30-2020 08:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered changed
information due to
instructions in
query
Oct-30-2020 08:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Data Entry:
ADVERSE EVENTchanged
information due to
instructions in
query
Oct-30-2020 08:38:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Keri Clarke
(pfe.clarkek2)Query 2: Opened ClinQuery: the
deleted text in the
specify box stated
that subject was
withdrawn due to an
AE. Please add
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135168
Page 144 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
details of the AE to
the AE log CRF and
consider if the
reason for
withdrawal subject
be updated to
Adverse Event.
Oct-29-2020 17:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to
"Status" is
PHYSICIAN
DECISION but
"Specify Status" is
Provided.
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel Pierce
(pfe.spierce)Data Entry:
PHYSICIAN DECISIONInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-29-2020 17:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry: Transcription Error
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rachel
Pierce
(pfe.spierce)Data Entry:
Subject experienced AE after VA
X #1.PI decided to not allow subj
ect to receive VAX#2Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135169
Page 145 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 16:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Feb/2/2021Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135170
Page 146 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 16:47:00
(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-04-2021 16:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135171
Page 147 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 16:47:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Linda
Welch
(pfe.lwelch)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135172
Page 148 of 149
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020 08:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDchanged information
due to instructions
in query
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-08-2020 23:41:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-08-2020 16:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-11-2020 15:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/8/2020date undated due to
Sponsor
instructions.
Oct-30-2020 08:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020changed information
due to instructions
in query
Oct-29-2020 17:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Oct-08-2020 23:41:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/8/2020Initial Entry
Oct-08-2020 16:13:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/8/2020Initial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135173
Page 149 of 149
***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, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111181 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 12:04:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Susann
Varano
(pfe.svarano)Data Entry:
Click Here to EnableInitial Entry
090177e196ae30a3\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135174