125742 S1 M5 CRF c4591001 1015 10151089

Document text

Page 1 of 145
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141162
Page 2 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug/21/2020
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141163
FDA-CBER-2021-5683-0141164
Page 4 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 Aug/21/2020
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141165
Page 5 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141166
Page 6 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141167
Page 7 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: UNK/UNK/1991
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergies]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141168
Page 8 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [185.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [30.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141169
Page 9 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: Aug/21/2020
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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141170
Page 10 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [60865]
3.Randomization Group: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141171
Page 11 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
Aug/21/2020
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 [BM8DW5]
5.bSample ID [BM8DW6]
5.cSample ID [BM8DW7]
5.dSample ID [BLD05Y]
5.eSample ID [BLD05Z]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141172
Page 12 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
Aug/21/2020
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 [BM8DW1]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141173
Page 13 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: Aug/21/2020 15:05
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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141174
Page 14 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141175
Page 15 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 Sep/11/2020
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141176
Page 16 of 145
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141177
Page 17 of 145
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: Sep/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141178
Page 18 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
Sep/11/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9J1X]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141179
Page 19 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: Sep/11/2020 11:18
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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141180
Page 20 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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/9/2020
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141181
Page 21 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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/9/2020
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 [BP9HMD]
5.bSample ID [BRTRXV]
5.cSample ID [BRTRXW]
5.dSample ID [BRTRXX]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141182
Page 22 of 145
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 Mar/8/2021
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141183
Page 23 of 145
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
Mar/8/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR70GW]
5.bSample ID [BSH1L5]
5.cSample ID [BSH1L6]
5.dSample ID [BSH1L4]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141184
Page 24 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141185
Page 25 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141186
Page 26 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141187
Page 27 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141188
Page 28 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141189
Page 29 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141190
Page 30 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141191
Page 31 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141192
Page 32 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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?
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141193
Page 33 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141194
Page 34 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141195
Page 35 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141196
Page 36 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 Sep/12/2020
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141197
Page 37 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141198
Page 38 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/12/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Called regarding eDiary symptoms reported. Is feeling better after taking
tylenol. Will recontact us with further concerns. No need for swab or
inperson visit.]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141199
Page 39 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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/9/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141200
Page 40 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141201
Page 41 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141202
Page 42 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141203
Page 43 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Fever  Sep/11/2020
22:00 NO
End Date Time:
Sep/13/2020 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  Whole arm pain - receiv
ed injection Sep/11/2020
22:00 NO
End Date Time:
Sep/13/2020 UNK:UN
K
 Repeating
Pages
 3.ADVERSE E
VENT 3  Swollen left axillary lym
ph node Sep/11/2020
22:00 NO
End Date Time:
Sep/18/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141204
Page 44 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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)[Fever]
4.Start Date Time: Sep/11/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/13/2020 UNK:UNK
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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141205
Page 45 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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[ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141206
Page 46 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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)[Whole arm pain - received injection]
4.Start Date Time: Sep/11/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/13/2020 UNK:UNK
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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141207
Page 47 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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[ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141208
Page 48 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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)[Swollen left axillary lymph node]
4.Start Date Time: Sep/11/2020 22:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 UNK:UNK
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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141209
Page 49 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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?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[ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141210
Page 50 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141211
Page 51 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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[ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141212
Page 52 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 Med
icationStart D
ateForm Instanc
e
 1.1  VACCINATIONS
 NO  Flu vaccine  Oct/8/2
020 Repeating
Pages
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141213
Page 53 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Flu vaccine]
5.Date: Oct/8/2020
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141214
Page 54 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141215
Page 55 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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?
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141216
Page 56 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141217
Page 57 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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?
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141218
Page 58 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141219
Page 59 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141220
Page 60 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141221
Page 61 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141222
Page 62 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141223
Page 63 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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?
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141224
Page 64 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141225
Page 65 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141226
Page 66 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141227
Page 67 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141228
Page 68 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141229
Page 69 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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 [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141230
Page 70 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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/15/2020
2.Erroneous Visit
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141231
Page 71 of 145
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141232
Page 72 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141233
Page 73 of 145
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141234
Page 74 of 145
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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: [ ]
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141235
Page 75 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/9/2020
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141236
Page 76 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141237
Page 77 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Elizabeth
Barnett Approved Mar-11-2021 10:38:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141238
Page 78 of 145
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-21-2020 16:03:07 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141239
Page 79 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Elizabeth
Barnett Approved Mar-11-2021 10:38:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor
Stannard N/A Mar-08-2021 11:50:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Jan-21-2021 19:21:30 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
Taylor
Stannard N/A Dec-23-2020 13:20:43 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141240
Page 80 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
N/A
Stephen Pelton  Approved Nov-16-2020 10:26:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenPelton, 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.
Taylor
Stannard N/A Nov-12-2020 11:46:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Oct-20-2020 20:18:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, 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.
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141241
Page 81 of 145
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:02:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-21-2020 16:02:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141242
Page 82 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/21/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141243
Page 83 of 145
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10151089Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 16:02:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141244
Page 84 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:03:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/21/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141245
Page 85 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141246
Page 86 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 16:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Migraines
Start Date: UNK/UNK/
1991
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020 16:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 16:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
MigrainesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020 16:06:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1991Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020 16:06:08 ACV0PFEINFP6000  Taylor Data Entry: Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141247
Page 87 of 145
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Stannard
(pfe.tstannard)YES
1.b
Date Location User Value Reason
Aug-21-2020 16:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Allergies
Start Date: UNK/UNK/
1995
Ongoing: YESInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141248
Page 88 of 145
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Aug-21-2020 16:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 16:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-21-2020 16:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-21-2020 16:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141249
Page 89 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
185.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141250
Page 90 of 145
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.8Initial Entry
7.a
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifie
r::1
Temperature: 98.6
Temperature U
nit:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141251
Page 91 of 145
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-21-2020 16:07:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141252
Page 92 of 145
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141253
Page 93 of 145
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-21-2020 16:08:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141254
Page 94 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:08:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020 16:08:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
60865Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141255
Page 95 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-22-2020 17:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-22-2020 17:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 17:38:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-22-2020 17:38:08
(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.
Aug-22-2020 17:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141256
Page 96 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-22-2020 17:38:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8DW5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 17:38:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DW5Initial Entry
5.b
Date Location User Value Reason
Aug-22-2020 17:38:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8DW6Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 17:38:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DW6Initial Entry
5.c
Date Location User Value Reason
Aug-22-2020 17:38:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8DW7Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 17:38:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DW7Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141257
Page 97 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d
Date Location User Value Reason
Aug-22-2020 17:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD05YInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-22-2020 17:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD05YInitial Entry
5.e
Date Location User Value Reason
Aug-22-2020 17:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD05ZInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-22-2020 17:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD05ZInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141258
Page 98 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-22-2020 17:39:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-22-2020 17:39:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 17:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-22-2020 17:39:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-22-2020 17:39:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141259
Page 99 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-22-2020 17:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8DW1Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 17:40:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DW1Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141260
Page 100 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/21/2020 15:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141261
Page 101 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-21-2020 16:09:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141262
Page 102 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Aug-21-2020 16:11:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141263
Page 103 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Sep-11-2020 13:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141264
Page 104 of 145
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 13:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020 13:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifie
r::1
Temperature: 98.0
Temperature U
nit:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 13:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-11-2020 13:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-11-2020 13:20:02 ACV0PFEINFP6000  Taylor Data Entry: Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141265
Page 105 of 145
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Stannard
(pfe.tstannard)F
2.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 13:20:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141266
Page 106 of 145
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141267
Page 107 of 145
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-11-2020 13:21:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141268
Page 108 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Sep-11-2020 18:25:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 18:25:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 18:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 18:25:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-11-2020 18:25:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141269
Page 109 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-11-2020 18:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9J1XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 18:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9J1XInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141270
Page 110 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020 11:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141271
Page 111 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-11-2020 13:21:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141272
Page 112 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-09-2020 13:42:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/9/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141273
Page 113 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-14-2020 12:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 12:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 12:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 12:24:30
(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-14-2020 12:24:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141274
Page 114 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-14-2020 12:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9HMDInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 12:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HMDInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020 12:38:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRTRXVInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 12:38:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRXVInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020 12:38:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRTRXWInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 12:38:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRXWInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141275
Page 115 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d
Date Location User Value Reason
Oct-14-2020 12:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BRTRXXInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020 12:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRXXInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141276
Page 116 of 145
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Mar-08-2021 11:50:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Mar/8/2021Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141277
Page 117 of 145
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Mar-09-2021 15:36:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 15:36:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 15:36:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 15:36:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-09-2021 15:36:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141278
Page 118 of 145
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mar-09-2021 15:36:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BR70GWInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-09-2021 15:36:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BR70GWInitial Entry
5.b
Date Location User Value Reason
Mar-09-2021 15:40:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH1L5Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-09-2021 15:40:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1L5Initial Entry
5.c
Date Location User Value Reason
Mar-09-2021 15:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH1L6Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-09-2021 15:40:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1L6Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141279
Page 119 of 145
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d
Date Location User Value Reason
Mar-09-2021 15:42:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH1L4Initial Entry
5.d Sample ID
Date Location User Value Reason
Mar-09-2021 15:42:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1L4Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141280
Page 120 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Sep-14-2020 11:26:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/12/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141281
Page 121 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Assessments
Date Location User Value Reason
Sep-14-2020 11:27:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 11:26:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome
is ticked however
'CONTACT
OUTCOME' form
is not entered.
Please review and
update as
appropriate.
Sep-14-2020 11:26:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141282
Page 122 of 145
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-14-2020 11:27:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-14-2020 11:27:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Contact:
Sep/12/2020
Contact Outcome:
VISIT NOT REQUIRED,
INVESTIGATOR DECISI
ONInitial Entry
3. Comments:
Date Location User ValueReason
Nov-13-2020
05:54:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Luke Cunliffe
(pfe.cunlil01)Query
2: Clo
sedResponse
satisfies query
Nov-12-2020
11:49:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query
2: An
swere
dAdded to AE
log, thanks!
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141283
Page 123 of 145
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-11-2020
00:16:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Sathenapalli Suguna
Srujan (pfe.srujas)Query
2: Op
enedSubject not in
the
reactogenicity
subset so
unplanned
contact CRF
unwarranted.
Please ensure
that any
adverse events
reported
during the
contact are
added to the
AE log or
SOD form
under potential
C-19 illness
visit as
appropriate.
Thank you.
Nov-10-2020
16:32:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Luke Cunliffe
(pfe.cunlil01)Query
2: Ca
ndidat
eSubject not in
the
reactogenicity
subset so
unplanned
contact CRF
unwarranted.
Please ensure
that any
adverse events
reported
during the
contact are
added to the
AE log or
SOD form
under potential
C-19 illness
visit as
appropriate.
Thank you.
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141284
Page 124 of 145
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
10:27:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Cavin van Schalkwyk
(pfe.vanscc01)Query
1: Clo
sedResponse
satisfies query
Sep-15-2020
15:01:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query
1: An
swere
dThis was
regarding the
COVID illness
diary.
Participant had
been filling it
out every day,
we have since
instructed him
not to do so.
Sep-15-2020
12:24:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Op
enedPer
Reactogenicity
Diary eCRF
the e-diary is
not collected
for this
subject. For
any
symptoms,
AEs, or other
key data
should be
collected on
the appropriate
page or
eDiary. If this
is already in
the predefined
list above
please choose
the appropriate
value. Please
review and
update as
necessary.
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141285
Page 125 of 145
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/12/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
"[vathm
SDQ=7562]"
Sep-14-2020
11:27:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data
Entry
:
Calle
d rega
rding
eDiar
y sym
ptoms
report
ed. Is
feelin
g bett
er afte
r takin
g tyle
nol.
Will r
econt
act us
with f
urther
conce
rns. N
o nee
d for s
wab o
r inpe
rson v
isit.Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141286
Page 126 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-09-2020 13:42:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020 13:42:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 13:42:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141287
Page 127 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141288
Page 128 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141289
Page 129 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141290
Page 130 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-12-2020 11:46:48
(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-12-2020 11:46:48
(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-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/13/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141291
Page 131 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141292
Page 132 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141293
Page 133 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-12-2020 11:47:31
(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-12-2020 11:47:31
(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-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Whole arm pain - received inj
ectionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/13/2020 UNK:UNKInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141294
Page 134 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141295
Page 135 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:47:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141296
Page 136 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-12-2020 11:48:16
(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-12-2020 11:48:16
(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
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Swollen left axillary lymph n
odeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/11/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/18/2020 UNK:UNKInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141297
Page 137 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141298
Page 138 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)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-12-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141299
Page 139 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-12-2020 11:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141300
Page 140 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-12-2020 11:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-12-2020 11:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-12-2020 11:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Nov-12-2020 11:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Flu vaccineInitial Entry
5. Date:
Date Location User Value Reason
Nov-12-2020 11:49:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/8/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141301
Page 141 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-23-2020 13:20:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141302
Page 142 of 145
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Dec-23-2020 13:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141303
Page 143 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Dec-23-2020 13:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-23-2020 13:20:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141304
Page 144 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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-09-2020 13:42:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-21-2020 16:08:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-21-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020 13:42:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/9/2020Initial Entry
Aug-21-2020 16:08:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
Aug-21-2020 16:03:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/21/2020Initial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141305
Page 145 of 145
***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: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151089 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
Oct-20-2020 20:18:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Elizabeth
Barnett
(pfe.ebarnett)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fec\Final\Final On: 01-Apr-2021 05:26 (GMT)
FDA-CBER-2021-5683-0141306