125742 S1 M5 CRF c4591001 1015 10151101

Document text

Page 1 of 133
***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: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141307
Page 2 of 133
***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: 10151101 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/24/2020
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141308
Page 3 of 133
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151101]
2.Birth Date: /1987
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141309
Page 4 of 133
***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: 10151101 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/25/2020
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141310
Page 5 of 133
***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: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141311
Page 6 of 133
***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: 10151101 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/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141312
Page 7 of 133
***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: 10151101 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:[Asthma]
Start Date: UNK/UNK/1987
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ADHD]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acne]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141313
Page 8 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [175.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [24.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141314
Page 9 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [66729]
3.Randomization Group: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141315
Page 10 of 133
***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: 10151101 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/25/2020
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 [BM8DYX]
5.bSample ID [BM8DYW]
5.cSample ID [BM8DYV]
5.dSample ID [BM8DYT]
5.eSample ID [BLD06S]
5.fSample ID [BLD06R]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141316
Page 11 of 133
***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: 10151101 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/25/2020
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 [BM8DYN]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141317
Page 12 of 133
***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: 10151101 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/25/2020 17:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?NO
If No, specify reason:
[Patient left urgently after five minutes, was feeling fine at
time of departure.]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141318
Page 13 of 133
***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: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141319
Page 14 of 133
***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: 10151101 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/15/2020
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141320
Page 15 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141321
Page 16 of 133
***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: 10151101 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/15/2020
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 [BP9J3G]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141322
Page 17 of 133
***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: 10151101 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/15/2020 14:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?NO
If No, specify reason:
[Patient did not want to stay the 30 minutes, left urgently.
Agreed to email us to follow up.]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141323
Page 18 of 133
***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: 10151101 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/13/2020
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141324
Page 19 of 133
***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: 10151101 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/13/2020
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 [BP9HMW]
5.bSample ID [BRTRZ9]
5.cSample ID [BRTRZB]
5.dSample ID [BRTRZG]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141325
Page 20 of 133
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141326
Page 21 of 133
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141327
Page 22 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141328
Page 23 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141329
Page 24 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141330
Page 25 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141331
Page 26 of 133
***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: 10151101 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:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141332
Page 27 of 133
***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: 10151101 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: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141333
Page 28 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141334
Page 29 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141335
Page 30 of 133
***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: 10151101 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?
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141336
Page 31 of 133
***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: 10151101 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:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141337
Page 32 of 133
***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: 10151101 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:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141338
Page 33 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141339
Page 34 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141340
Page 35 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141341
Page 36 of 133
***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: 10151101 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/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141342
Page 37 of 133
***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: 10151101 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: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141343
Page 38 of 133
***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: 10151101 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:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141344
Page 39 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141345
Page 40 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Gout  Oct/1/2020
06:00 NO
End Date Time:
Oct/12/2020 08:00
 Repeating
Pages
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141346
Page 41 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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)[Gout]
4.Start Date Time: Oct/1/2020 06:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/12/2020 08:00
6.Toxicity Grade: 1
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141347
Page 42 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141348
Page 43 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141349
Page 44 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141350
Page 45 of 133
***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: 10151101 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[ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141351
Page 46 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141352
Page 47 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141353
Page 48 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141354
Page 49 of 133
***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: 10151101 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?
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141355
Page 50 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141356
Page 51 of 133
***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: 10151101 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?
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141357
Page 52 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141358
Page 53 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141359
Page 54 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141360
Page 55 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10151101 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:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141361
Page 56 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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?
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141362
Page 57 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141363
Page 58 of 133
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141364
Page 59 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141365
Page 60 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141366
Page 61 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141367
Page 62 of 133
***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: 10151101 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 [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141368
Page 63 of 133
***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: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141369
Page 64 of 133
***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: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141370
Page 65 of 133
***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: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141371
Page 66 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141372
Page 67 of 133
***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: 10151101 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: [ ]
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141373
Page 68 of 133
***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: 10151101 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/13/2020
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141374
Page 69 of 133
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141375
Page 70 of 133
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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 Jan-21-2021 19:24:40 (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.
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141376
Page 71 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-25-2020 17:55:22 (UTC-05:00)
Eastern Time (US & Canada)Taylor
Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141377
Page 72 of 133
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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 Jan-21-2021 19:24:40 (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 14:15:26 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Oct-20-2020 21:31:52 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141378
Page 73 of 133
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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.
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141379
Page 74 of 133
***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: 10151101 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-24-2020
16:28:24
(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-24-2020
16:28:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141380
Page 75 of 133
***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: 10151101 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-26-2020
11:31:41
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response
satisfies
query
Aug-26-2020
10:28:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 1: Answere
dPatient came
in and
consented on
8/24/2020
but could not
stay for the
full visit.
Returned on
8/25/2020 to
complete
visit.
Aug-25-2020
17:55:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date
Informed
Consent
Obtained is
not the same
as the Date
of Visit.
Please
correct as
necessary.
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141381
Page 76 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-24-2020
16:28:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Co
nsent Obtained
Aug/24/2020Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141382
Page 77 of 133
***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: 10151101 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-24-2020
16:28:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10151101Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020
16:28:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1987Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020
16:28:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141383
Page 78 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-24-2020
16:28:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORIG
INInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020
16:28:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141384
Page 79 of 133
***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: 10151101 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-25-2020
17:55:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/25/2020Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141385
Page 80 of 133
***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: 10151101 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-25-2020
17:55:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020
17:55:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020
17:55:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141386
Page 81 of 133
***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: 10151101 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-25-2020
18:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Asthma
Start Date: UNK/U
NK/198
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020
18:03:13
(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-25-2020
18:03:13
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
AsthmaInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141387
Page 82 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-25-2020
18:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1987Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020
18:03:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-25-2020
18:03:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:ADHD
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141388
Page 83 of 133
***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: 10151101 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-25-2020
18:03:30
(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-25-2020
18:03:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ADHDInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020
18:03:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020
18:03:30ACV0PFEINFP6000  Taylor
StannardData Entry:
YESInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141389
Page 84 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard)
1.c
Date Location User Value Reason
Aug-25-2020
18:03:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Acne
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141390
Page 85 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020
18:03:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
18:03:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
AcneInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020
18:03:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020
18:03:51ACV0PFEINFP6000  Taylor
StannardData Entry:
YESInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141391
Page 86 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard)
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141392
Page 87 of 133
***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: 10151101 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-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
175.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141393
Page 88 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020
18:04:14
(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
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.4Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Id
entifier::1
Temperat
ure:97.0Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141394
Page 89 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020
18:04:14
(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-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
97.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141395
Page 90 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
18:04:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141396
Page 91 of 133
***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: 10151101 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-25-2020
18:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020
18:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
66729Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141397
Page 92 of 133
***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: 10151101 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-26-2020
10:44:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
10:44:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020
10:45:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-26-2020
10:44:56
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141398
Page 93 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
10:44:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
10:45:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8DY
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
10:45:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DYXInitial Entry
5.b
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141399
Page 94 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-26-2020
10:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8DY
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020
10:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DYWInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020
10:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8DY
VInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141400
Page 95 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Aug-26-2020
10:45:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DYVInitial Entry
5.d
Date Location User Value Reason
Aug-26-2020
10:45:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8DY
TInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020
10:45:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DYTInitial Entry
5.e
Date Location User Value Reason
Aug-26-2020
10:45:56ACV0PFEINFP6000  Taylor
StannardData Entry:
Sample I BLD06Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141401
Page 96 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) D: S
5.e Sample ID
Date Location User Value Reason
Aug-26-2020
10:45:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD06SInitial Entry
5.f
Date Location User Value Reason
Aug-26-2020
10:46:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD06
RInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-26-2020
10:46:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD06RInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141402
Page 97 of 133
***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: 10151101 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-26-2020
10:43:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020
10:43:58
(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-26-2020
10:44:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-26-2020
10:43:58
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141403
Page 98 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-26-2020
10:43:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020
10:44:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8DY
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020
10:44:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8DYNInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141404
Page 99 of 133
***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: 10151101 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-25-2020
18:05:46
(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-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141405
Page 100 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/25/2020 17:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020
21:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141406
Page 101 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-27-2020
04:13:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Closed per site
response
Aug-26-2020
10:29:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Original value
is correct
Aug-26-2020
06:33:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Nancy
Vedamuthu
(pfe.vedamn)Query 1: Opened PDQ:
Response to
question for
observation
post dose is
'NO'. Please
review and
correct or
confirm.
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141407
Page 102 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-25-2020
18:05:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
If No, specify reas
on:
Patient left urge
ntly after five mi
nutes, was feelin
g fine at time of
departure.Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141408
Page 103 of 133
***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: 10151101 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-25-2020
17:56:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141409
Page 104 of 133
***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: 10151101 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-15-2020
15:25:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141410
Page 105 of 133
***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: 10151101 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-15-2020
15:25:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020
15:25:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Id
entifier::1
Temperatu
re:96.6
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020
15:25:40
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141411
Page 106 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-17-2020
03:21:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response
satisfies query
Sep-16-2020
10:50:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Confirmed
96.6, not
clinically
signficiant.
Sep-15-2020
15:25:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature
96.6 F is
outside of
Normal Range
97 - 99.5 F.
Sep-15-2020
15:25:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
96.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020
15:25:40
(UTC-05:00)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141412
Page 107 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020
15:25:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141413
Page 108 of 133
***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: 10151101 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-17-2020
13:04:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
13:04:20
(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-17-2020
13:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
13:04:20
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141414
Page 109 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
13:04:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
13:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BP9J3
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
13:04:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9J3GInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141415
Page 110 of 133
***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: 10151101 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-15-2020
15:27:21
(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-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141416
Page 111 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/15/2020 14:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141417
Page 112 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-18-2020
07:50:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Avinash
Gawas
(pfe.gawasa)Query 1: Closed closed per
SITE
response,
added to PD
tracker
Sep-17-2020
11:09:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Original value
is correct
Sep-17-2020
05:46:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Avinash
Gawas
(pfe.gawasa)Query 1: Opened PDQ:
Response to
question for
observation
post dose is
'NO'. Please
review and
correct or
confirm.
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141418
Page 113 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-15-2020
15:27:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
If No, specify reas
on:
Patient did not
want to stay the
30 minutes, left
urgently. Agreed
to email us to fol
low up.Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141419
Page 114 of 133
***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: 10151101 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-13-2020
08:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
Oct/13/2020Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141420
Page 115 of 133
***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: 10151101 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
13:01:12
(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
13:01:12
(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
13:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-14-2020
13:01:12
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141421
Page 116 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-14-2020
13:01:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-14-2020
13:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BP9HM
WInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020
13:01:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HMWInitial Entry
5.b
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141422
Page 117 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-14-2020
13:12:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BRTRZ
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020
13:12:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRZ9Initial Entry
5.c
Date Location User Value Reason
Oct-14-2020
13:12:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BRTRZ
BInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141423
Page 118 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-14-2020
13:12:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRZBInitial Entry
5.d
Date Location User Value Reason
Oct-14-2020
13:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BRTRZ
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-14-2020
13:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BRTRZGInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141424
Page 119 of 133
***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: 10151101 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-13-2020
08:30:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020
08:30:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020
08:30:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141425
Page 120 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Casey
Norton
(pfe.cnorton)Form Created
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141426
Page 121 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020
08:33:23
(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
Oct-16-2020
17:25:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Patricia
Banchero
(pfe.banchp)Query 1: Closed Response
satisfies query
Oct-15-2020
14:54:56
(UTC-05:00)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Subject did
not have a
prior medical
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141427
Page 122 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)history of
gout. This is a
self diagnosed
episode
Oct-14-2020
21:47:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Patricia
Banchero
(pfe.banchp)Query 1: Opened GPDCLIN:
Please review
and confirm if
subject had
prior medical
history of
gout.
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey Norton
(pfe.cnorton)Data Entry:
GoutInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
Oct/1/2020 06:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141428
Page 123 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada) Oct/12/2020 08:00
6. Toxicity Grade:
Date Location User Value Reason
Oct-22-2020
08:38:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Sharreda
Cornes
(pfe.cornes09)Query 1: Closed site confirmed
updated
Oct-21-2020
16:18:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Source has
been updated,
thank you!
Oct-18-2020
16:02:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Kirenda Welch
(pfe.welchk04)Query 1: Opened Toxicity grade
and causality
assessment by
investigator is
not noted in
source. please
confirm.
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey Norton
(pfe.cnorton)Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141429
Page 124 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)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
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
RELATEDInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141430
Page 125 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-13-2020
08:33:23ACV0PFEINFP6000  Casey
NortonData Entry:
RECOVERED/RESInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141431
Page 126 of 133
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.cnorton) OLVED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020
08:33:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Casey
Norton
(pfe.cnorton)Data Entry:
NOInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141432
Page 127 of 133
***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: 10151101 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
14:15:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141433
Page 128 of 133
***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: 10151101 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
14:15:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141434
Page 129 of 133
***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: 10151101 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
14:15:26
(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
14:15:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141435
Page 130 of 133
***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: 10151101 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-13-2020
08:30:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020
18:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-25-2020
17:55:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-18-2020
01:33:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Swapna
Varikuti
(pfe.variks)Query 1: Closed Response
satisfies query
Dec-17-2020
15:24:35ACV0PFEINFP6000  Taylor
StannardQuery 1: Answere
dSubject spoke
with PI, hit yes
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141436
Page 131 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) by error.
Dec-17-2020
14:35:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 1: Opened Illness eDiary:
Subject
reported "Yes"
for the
question "Have
you
experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
13DEC2020.
But there is no
COVID Illness
visit reported
in the database.
Please clarify.
Oct-13-2020
08:30:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-25-2020
18:04:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
Aug-25-2020 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141437
Page 132 of 133
***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: 10151101 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
17:55:37
(UTC-05:00)
Eastern Time (US
& Canada)(autocalc) Aug/25/2020
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141438
Page 133 of 133
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151101 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
21:31:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Elizabeth
Barnett
(pfe.ebarnett)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fe6\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141439