Document text
Page 1 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140492
Page 2 of 205
***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: 10151011 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/13/2020
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140493
Page 3 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151011]
2.Birth Date: 1990
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:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0140494
Page 4 of 205
***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: 10151011 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/13/2020
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140495
Page 5 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140496
Page 6 of 205
***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: 10151011 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/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140497
Page 7 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140498
Page 8 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [205.0]
3.Unit: LB
4.Height: [75.0]
5.Unit: in
6.Body Mass Index: [25.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140499
Page 9 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [48847]
3.Randomization Group: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140500
Page 10 of 205
***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: 10151011 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/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 [BLD00Z]
5.bSample ID [BLD010]
5.cSample ID [BM8F79]
5.dSample ID [BM8F7B]
5.eSample ID [BM8F7C]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140501
Page 11 of 205
***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: 10151011 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/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 [BM8F78]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140502
Page 12 of 205
***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: 10151011 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/13/2020 13:34
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?YES
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140503
Page 13 of 205
***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: 10151011 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
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140504
Page 14 of 205
***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: 10151011 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/3/2020
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140505
Page 15 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140506
Page 16 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140507
Page 17 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140508
Page 18 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140509
Page 19 of 205
***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: 10151011 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/3/2020
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 [BP9HWP]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140510
Page 20 of 205
***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: 10151011 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/3/2020 13:18
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?YES
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140511
Page 21 of 205
***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: 10151011 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/1/2020
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140512
Page 22 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140513
Page 23 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140514
Page 24 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140515
Page 25 of 205
***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: 10151011 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/1/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLD0K8]
5.bSample ID [BLD0K9]
5.cSample ID [BLD0KH]
5.dSample ID [BP9HJH]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140516
Page 26 of 205
***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: 10151011 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:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140517
Page 27 of 205
***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: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140518
Page 28 of 205
***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: 10151011 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 [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140519
Page 29 of 205
***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: 10151011 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 [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140520
Page 30 of 205
***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: 10151011 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?
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140521
Page 31 of 205
***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: 10151011 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:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140522
Page 32 of 205
***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: 10151011 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:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140523
Page 33 of 205
***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: 10151011 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 [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140524
Page 34 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140525
Page 35 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140526
Page 36 of 205
***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: 10151011 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/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140527
Page 37 of 205
***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: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140528
Page 38 of 205
***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: 10151011 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:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140529
Page 39 of 205
***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: 10151011 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 [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140530
Page 40 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
1.ADVERS
E EVENT 1 Exposure During P
artner Pregnancy Nov/25/2020
UNK:UNK YES Repeating
Pages
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140531
Page 41 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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)[Exposure During Partner Pregnancy]
4.Start Date Time: Nov/25/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140532
Page 42 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[Pregnancy occured unrelated to vaccine]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140533
Page 43 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140534
Page 44 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140535
Page 45 of 205
***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: 10151011 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[ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140536
Page 46 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140537
Page 47 of 205
***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: 10151011 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: //
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140538
Page 48 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140539
Page 49 of 205
***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: 10151011 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?
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140540
Page 50 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140541
Page 51 of 205
***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: 10151011 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?
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140542
Page 52 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140543
Page 53 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140544
Page 54 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140545
Page 55 of 205
***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: 10151011 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:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140546
Page 56 of 205
***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: 10151011 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?
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140547
Page 57 of 205
***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: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140548
Page 58 of 205
***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: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140549
Page 59 of 205
***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: 10151011 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 Jan/19/2021
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140550
Page 60 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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 per other protocol allowance(s) and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140551
Page 61 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140552
Page 62 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140553
Page 63 of 205
***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: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140554
Page 64 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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 Jan/28/2021
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140555
Page 65 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/28/2021
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140556
Page 66 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140557
Page 67 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/28/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140558
Page 68 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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:
Jan/28/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSH1CR]
5.bSample ID [BSH1CS]
5.cSample ID [BSH1CJ]
5.dSample ID [BR70B3]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140559
Page 69 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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:
Jan/28/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR709Z]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140560
Page 70 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 16:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140561
Page 71 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140562
Page 72 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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:
Feb/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR70DR]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140563
Page 73 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/18/2021 13:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140564
Page 74 of 205
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140565
Page 75 of 205
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140566
Page 76 of 205
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140567
Page 77 of 205
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140568
Page 78 of 205
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140569
Page 79 of 205
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140570
Page 80 of 205
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140571
Page 81 of 205
***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: 10151011 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/1/2020
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140572
Page 82 of 205
***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: 10151011 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
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140573
Page 83 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Elizabeth
Barnett Approved Mar-11-2021 10:13:43 (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.
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140574
Page 84 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-13-2020 16:45:28 (UTC-05:00)
Eastern Time (US & Canada)Taylor
Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140575
Page 85 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-13-2020 16:45:54 (UTC-05:00)
Eastern Time (US & Canada)Taylor
Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140576
Page 86 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Jan-29-2021 12:44:13 (UTC-05:00)
Eastern Time (US & Canada)Taylor
Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140577
Page 87 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-03-2021 14:01:55 (UTC-05:00)
Eastern Time (US & Canada)Taylor
Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140578
Page 88 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Elizabeth
Barnett Approved Mar-11-2021 10:13:43 (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 Jan-29-2021 12:35:36 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Oct-05-2020 12:50:33 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140579
Page 89 of 205
***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: 10151011 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.
Taylor
Stannard N/A Oct-01-2020 13:50:02 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Sep-12-2020 11:54:07 (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.
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140580
Page 90 of 205
***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: 10151011 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-13-2020
16:44:50
(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-13-2020
16:44:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140581
Page 91 of 205
***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: 10151011 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-13-2020
16:44:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/13/2020Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140582
Page 92 of 205
***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: 10151011 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-13-2020
16:44:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10151011Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020
16:44:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1990Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020
16:45:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0140583
Page 93 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-13-2020
16:45:14
(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-13-2020
16:45:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140584
Page 94 of 205
***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: 10151011 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-13-2020
16:45:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/13/2020Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140585
Page 95 of 205
***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: 10151011 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-13-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140586
Page 96 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
205.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140587
Page 97 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
75.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020
16:46:37
(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-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.6Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Id
entifier::1
Temperat
ure:97.7Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140588
Page 98 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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-13-2020
16:46:37
(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-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140589
Page 99 of 205
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020
16:46:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140590
Page 100 of 205
***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: 10151011 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-13-2020
16:47:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020
16:47:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
48847Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140591
Page 101 of 205
***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: 10151011 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-13-2020
17:23:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
17:23:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020
17:24:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
17:23:44
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140592
Page 102 of 205
***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: 10151011 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-13-2020
17:23:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
17:24:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD00
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
17:24:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD00ZInitial Entry
5.b
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140593
Page 103 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-13-2020
17:24:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BLD01
0Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020
17:24:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD010Initial Entry
5.c
Date Location User Value Reason
Aug-13-2020
17:24:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8F7
9Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140594
Page 104 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Aug-13-2020
17:24:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F79Initial Entry
5.d
Date Location User Value Reason
Aug-13-2020
17:24:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8F7
BInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020
17:24:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F7BInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020
17:25:03ACV0PFEINFP6000 Taylor
StannardData Entry:
Sample I BM8F7Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140595
Page 105 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) D: C
5.e Sample ID
Date Location User Value Reason
Aug-13-2020
17:25:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F7CInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140596
Page 106 of 205
***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: 10151011 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-13-2020
17:23:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020
17:23:15
(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-13-2020
17:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-13-2020
17:23:15
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140597
Page 107 of 205
***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: 10151011 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-13-2020
17:23:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020
17:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8F7
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020
17:23:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8F78Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140598
Page 108 of 205
***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: 10151011 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-13-2020
16:47:32
(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-13-2020
16:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020
16:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140599
Page 109 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-13-2020
16:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/13/2020 13:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020
16:47:32
(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-13-2020
16:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-13-2020
16:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140600
Page 110 of 205
***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: 10151011 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-13-2020
16:47:32
(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-13-2020
16:47:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140601
Page 111 of 205
***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: 10151011 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-13-2020
16:47:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140602
Page 112 of 205
***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: 10151011 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-03-2020
13:29:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140603
Page 113 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140604
Page 114 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140605
Page 115 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.b Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140606
Page 116 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-03-2020
13:30:02ACV0PFEINFP6000 Taylor
StannardData Entry:
Symptom:: CInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140607
Page 117 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.e
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140608
Page 118 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140609
Page 119 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or
systemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140610
Page 120 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140611
Page 121 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-03-2020 ACV0PFEINFP6000 Taylor Data Entry: Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140612
Page 122 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)Stannard
(pfe.tstannard)Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140613
Page 123 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h Symptom:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140614
Page 124 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
REDNESSInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140615
Page 125 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140616
Page 126 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140617
Page 127 of 205
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were injectio
n site reactio
ns present on
the last day t
he Subject D
iary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-03-2020
13:30:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140618
Page 128 of 205
***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: 10151011 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-03-2020
13:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/3/2020Initial Entry
2.a
Date Location User Value Reason
Sep-03-2020
13:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Id
entifier::1
Temperatu
re:97.7
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-03-2020
13:43:05
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140619
Page 129 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-03-2020
13:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-03-2020
13:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-03-2020
13:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140620
Page 130 of 205
***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: 10151011 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-04-2020
11:21:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020
11:21:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020
11:21:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-04-2020
11:21:37
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140621
Page 131 of 205
***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: 10151011 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-04-2020
11:21:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020
11:21:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BP9HW
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020
11:21:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HWPInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140622
Page 132 of 205
***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: 10151011 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-03-2020
13:30:42
(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-03-2020
13:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020
13:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140623
Page 133 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-03-2020
13:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/3/2020 13:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020
13:30:42
(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-03-2020
13:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020
13:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140624
Page 134 of 205
***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: 10151011 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-03-2020
13:30:42
(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-03-2020
13:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140625
Page 135 of 205
***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: 10151011 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-01-2020
13:50:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/1/2020Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140626
Page 136 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140627
Page 137 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140628
Page 138 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.b Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140629
Page 139 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.c Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020
13:50:36ACV0PFEINFP6000 Taylor
StannardData Entry:
Symptom:: CInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140630
Page 140 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.d Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.e
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140631
Page 141 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140632
Page 142 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or
systemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140633
Page 143 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140634
Page 144 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.g Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-01-2020 ACV0PFEINFP6000 Taylor Data Entry: Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140635
Page 145 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)Stannard
(pfe.tstannard)Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AIN
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140636
Page 146 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h Symptom:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140637
Page 147 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
REDNESSInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140638
Page 148 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140639
Page 149 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140640
Page 150 of 205
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Were injectio
n site reactio
ns present on
the last day t
he Subject D
iary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020
13:50:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140641
Page 151 of 205
***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: 10151011 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-02-2020
13:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020
13:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020
13:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-02-2020
13:43:30
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140642
Page 152 of 205
***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: 10151011 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-02-2020
13:43:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020
13:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD0K
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020
13:43:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0K8Initial Entry
5.b
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140643
Page 153 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-02-2020
13:43:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD0K
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020
13:43:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0K9Initial Entry
5.c
Date Location User Value Reason
Oct-02-2020
13:43:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD0K
HInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140644
Page 154 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-02-2020
13:43:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0KHInitial Entry
5.d
Date Location User Value Reason
Oct-02-2020
13:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BP9HJ
HInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-02-2020
13:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HJHInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140645
Page 155 of 205
***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: 10151011 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-02-2020
13:26:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020
13:26:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020
13:26:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140646
Page 156 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140647
Page 157 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021
12:44:03
(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
Mar-04-2021
11:48:46
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Mar-02-2021
09:59:23
(UTC-05:00)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answere
dCondoms are no
longer in use.
Will fax update
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140648
Page 158 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)today.
Feb-17-2021
02:50:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued
:OpenedClinical- Thank
you; clarify in
PG Safety
report if
condom barrier
method is now
used AFTER
Pregnancy start
date & during
VAX 3/4
Feb-10-2021
15:13:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answere
dBoth forms
were used
during the trial
prior to
pregnancy.
Feb-08-2021
20:47:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued
:OpenedClinical Please
clarify if
condom + oral
contraceptives
was the method
used during the
trial, prior to
Pregnancy (as
oral
contraceptives
will not be
taken while
PG); clarify is
condom barrier
is the method
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140649
Page 159 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
used after
Pregnancy start
date & during
VAX 3/4
Feb-08-2021
20:34:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Query closed;
will follow for
requested
maternal age
information.
Feb-08-2021
09:47:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Closed Response
satisfies query
Feb-04-2021
11:38:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 4: Answere
dUpdated term
for PG/SAE.
Faxed on
4feb2021
Feb-04-2021
11:37:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 3: Answere
dMaternal age
currently
unknown. Will
update PG/SAE
once
information is
available.
Feb-04-2021
11:37:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answere
dSubject reported
condoms and
oral
contraceptives.
Added to
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140650
Page 160 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
PG/SAE. Faxed
on 4feb2021
Feb-03-2021
14:44:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued
:OpenedClinical PG
safety report
states subject
was instructed
to continue
appropriate
contraception
after VAX3;
please specify
the
contraceptive
method (e.g.
barrier or
other); also
contraception
before PG
Feb-03-2021
14:43:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Reissued
:OpenedClinical Thank
you; please
submit the
mother's age if
known
Feb-03-2021
14:42:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Reissued
:OpenedClinical - Thank
you; please
submit the
updated event
term to the PG
safety report
Feb-03-2021
14:09:00ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answere
dChanged
Information
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140651
Page 161 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US & Canada)
Feb-03-2021
14:09:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Exposure During
Partner PregnancyChanged
Information
Feb-03-2021
13:46:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 4: Opened Clinical As per
CRF CG
8.50.2.5, a
healthy
pregnancy is not
an AE term;
instead
“Exposure
During Partner
Pregnancy” will
be recorded as
an AE in the
CRF until 6
months after the
last dose of
study
intervention
Feb-02-2021
13:01:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-02-2021 ACV0PFEINFP6000 auto query Query 3: Answere Changed
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140652
Page 162 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11:20:02
(UTC-05:00)
Eastern Time
(US & Canada)(autoquery) d Information
Feb-02-2021
11:20:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answere
dChanged
Information
Feb-02-2021
11:20:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged
Information
Feb-02-2021
11:20:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Partner pregnancyChanged
Information
Feb-01-2021
15:28:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical Please
submit the PG
partner
information
(age, med Hx,
obstetric
history, meds,
social habits
(alcohol/drugs)
Feb-01-2021
15:22:20
(UTC-05:00)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical PG
safety report
states subject
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140653
Page 163 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US & Canada)was instructed
to continue
appropriate
contraception
after VAX3;
please specify
the
contraceptive
method (e.g.
barrier or
other).
Feb-01-2021
15:19:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Event
term is EDP;
however, event
term in PG
safety report is
'Partner
Pregnancy'.
Please review,
harmonize
reporting, and
update in the
applicable
location.
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Exposure during p
regnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140654
Page 164 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-17-2021
02:49:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Feb-10-2021
15:13:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answer
edAdded to SAE
form section 11
page 2 "Onset
date"25nov2020.
I don't
understand what
else needs to be
done.
Feb-08-2021
20:43:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical - Thank
you; however the
most recent
PG/SAE report
does NOT have
any start date.
Please enter in
the EVENT
section of the
SAE form under
the term
Exposure during
Partner
Pregnancy, at
START
Feb-08-2021
20:39:27
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed update wording
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140655
Page 165 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US & Canada)
Feb-08-2021
20:32:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissue
d:OpenedClinical Start
date here is
25Nov20;
however, start
date of PG report
is 28Dec20
(estimated date
of Conception).
Please review,
harmonize
reporting &
update where
applicable
Feb-04-2021
11:36:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answer
edAdded to
PG/SAE. Faxed
on 4feb2021
Feb-03-2021
13:45:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissue
d:OpenedClinical Thank
you; however
most recent
event report is
blank for START
in the Event
section.
Feb-03-2021
11:41:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answer
edSubmitted on
28Jan2021 by
Dr. Barnett
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140656
Page 166 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-02-2021
13:06:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissue
d:OpenedClinical Thank
you, please
submit a PG
safety update
with the current
PG start date,
and other
requested info
Feb-02-2021
11:20:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edNew Information
Feb-02-2021
11:20:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Nov/25/2020 UN
K:UNKNew Information
Feb-01-2021
15:26:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical NO PG
start date in
Safety report.
Ultrasound
measurement of
the fetus during
the first trimester
is the most
accurate method;
in the absence of
US, 1st day of
the last
menstrual period
(LMP; 25Nov20)
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140657
Page 167 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
should be used to
estimate
conception:
update
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/28/2021 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021
12:44:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Not ApplicableInitial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140658
Page 168 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Feb-09-2021
13:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto
Query
Feb-08-2021
20:44:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response
satisfies query
Feb-08-2021
11:55:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidat
eFor AE
Exposure
During Partner
Pregnancy:
Response to
"Is the adverse
event serious?"
is 'No' but
"Serious
Adverse Event
Number" is
present.
Feb-08-2021
11:55:06
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 3: Answere
dChanged
Information
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140659
Page 169 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
Feb-08-2021
11:55:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOChanged
Information
Feb-08-2021
09:38:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical
Followup; AE
form still has
Serious=Yes.
As per CRF
CG 8.50.2.5,
an “Exposure
During Partner
Pregnancy” is
not an SAE
[despite using
similar forms
to report
pregnancy];
only abnormal
outcomes of
pregnancy are
evaluated for
serious criteria
Feb-02-2021
13:02:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Feb-02-2021
11:21:44ACV0PFEINFP6000 Taylor
StannardQuery 2: Answere
dChanged data
per query
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140660
Page 170 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard)
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140661
Page 171 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-01-2021
15:20:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical As
per CRF CG
8.50.2.5, a
healthy
pregnancy is
not an AE
term; instead
“Exposure
during
Pregnancy” or
'Exposure
during Partner
Pregnancy'
will be
recorded as an
AE in the CRF
until 6 months
after the last
dose of study
intervention
Feb-01-2021 ACV0PFEINFP6000 auto query Query 1: Deleted Close Auto
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140662
Page 172 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10:24:47
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Query
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eFor AE
Exposure
during
pregnancy:
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Is this serious ev
ent associated wi
th congenital ano
maly or birth def
ect?
NO
Did this serious e
vent result in dea
th?
NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140663
Page 173 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Did this serious e
vent require or pr
olong hospitaliza
tion?
NO
Did this serious e
vent result in per
sistent or signific
ant disability/inc
apacity?
NO
Is this serious ev
ent life threatenin
g?
NO
Other medically i
mportant serious
event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-29-2021
12:44:03ACV0PFEINFP6000 Taylor
StannardData Entry:
NOInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140664
Page 174 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard)
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:
OTHER
If Other, specify
:
Pregnancy occ
ured unrelated
to vaccineInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140665
Page 175 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-04-2021
23:55:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 3: Closed Response
satisfies query
Feb-04-2021
11:40:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 3: Answere
dNo end date
for pregnancy
yet, outcome
is still
unknown.
Feb-03-2021 ACV0PFEINFP6000 auto query Query 3: Opened For AE
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140666
Page 176 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
14:09:00
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Exposure
During
Partner
Pregnancy:
Response to
"What was the
outcome of
this adverse
event?" is
'Unknown' but
End
Date/Time is
provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Feb-02-2021
13:08:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Clinical - no
end date is
reported for
this event
Feb-02-2021
11:23:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 2: Answere
dPregnancy
outcome still
unknown, will
update when
more
information is
available.
Feb-02-2021
11:20:02
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE
Partner
pregnancy:
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140667
Page 177 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)Response to
"What was the
outcome of
this adverse
event?" is
'Unknown' but
End
Date/Time is
provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Feb-01-2021
02:24:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Astrud van der
Merwe
(pfe.vandea62)Query 1: Closed Response
satisfies query
Jan-29-2021
12:44:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Query 1: Answere
dOriginal value
is correct
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE
Exposure
during
pregnancy:
Response to
"What was the
outcome of
this adverse
event?" is
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140668
Page 178 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
'Unknown' but
End
Date/Time is
provided or
"Is the adverse
event still
ongoing?" is
marked "Yes".
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
UNKNOWNInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021
12:44:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-09-2021
13:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Data Entry: not serious
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140669
Page 179 of 205
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-01-2021
10:24:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Data Entry:
2021086993Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140670
Page 180 of 205
***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: 10151011 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
Jan-29-2021
12:35:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/19/2021Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140671
Page 181 of 205
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
Jan-29-2021
12:35:55
(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 per other
protocol allowanc
e(s) and confirme
d to have receive
d only placebo at
Vaccination 1/2Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140672
Page 182 of 205
***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: 10151011 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
Jan-29-2021
12:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-29-2021
12:35:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140673
Page 183 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021
14:01:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/28/2021Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140674
Page 184 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
Feb-03-2021
14:01:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Jan/28/2021Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140675
Page 185 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
Feb-03-2021
14:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/28/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-03-2021
14:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-03-2021
14:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140676
Page 186 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
Feb-03-2021
14:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021
14:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021
14:09:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
14:09:20
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140677
Page 187 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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.
Feb-03-2021
14:09:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
14:09:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BSH1C
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
14:09:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1CRInitial Entry
5.b
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140678
Page 188 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Feb-03-2021
14:09:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BSH1C
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-03-2021
14:09:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1CSInitial Entry
5.c
Date Location User Value Reason
Feb-03-2021
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BSH1C
JInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140679
Page 189 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Feb-03-2021
14:20:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1CJInitial Entry
5.d
Date Location User Value Reason
Feb-03-2021
14:25:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BR70B
3Initial Entry
5.d Sample ID
Date Location User Value Reason
Feb-03-2021
14:25:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BR70B3Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140680
Page 190 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10151011 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
Feb-03-2021
14:02:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021
14:02:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021
14:03:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-03-2021
14:02:56
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140681
Page 191 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10151011 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.
Feb-03-2021
14:02:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021
14:03:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BR709
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021
14:03:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
BR709ZInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140682
Page 192 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140683
Page 193 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Jan/28/2021 16:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140684
Page 194 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Actual Dose:
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-03-2021
14:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-03-2021
14:03:39ACV0PFEINFP6000 Taylor
StannardData Entry:
YESInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140685
Page 195 of 205
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard)
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140686
Page 196 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021
03:19:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Rose
Madelein
(pfe.rosem19)Query 1: Closed Response
satisfies
query
Feb-22-2021
15:08:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Casey Norton
(pfe.cnorton)Query 1: Answered Changed data
per query
Feb-22-2021
07:09:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Kindly
consider to
update
missing
SWAB PFE
form or else
clarify. Thank
you.
Feb-18-2021
14:24:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Feb/18/2021Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140687
Page 197 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10151011 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
Feb-22-2021
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-22-2021
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021
15:07:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-22-2021
15:07:00
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140688
Page 198 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10151011 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.
Feb-22-2021
15:07:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Casey
Norton
(pfe.cnorton)Data Entry:
YES
Date of Collection:
Feb/18/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021
15:07:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Casey
Norton
(pfe.cnorton)Data Entry:
Sample ID
:BR70D
RInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-22-2021
15:07:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Casey
Norton
(pfe.cnorton)Data Entry:
BR70DRInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140689
Page 199 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 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
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140690
Page 200 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Feb/18/2021 13:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140691
Page 201 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021
14:25:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-18-2021
14:25:15ACV0PFEINFP6000 Taylor
StannardData Entry:
YESInitial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140692
Page 202 of 205
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard)
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140693
Page 203 of 205
***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: 10151011 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-02-2020
13:26:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020
16:47:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-13-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-02-2020
13:26:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/1/2020Initial Entry
Aug-13-2020
16:47:04ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140694
Page 204 of 205
***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-13-2020
16:45:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
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***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: 10151011 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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1. Casebook Signature
Date Location User Value Reason
Sep-11-2020
19:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
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090177e196ae3fe9\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140696