125742 S1 M5 CRF c4591001 1015 10151047

Document text

Page 1 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140851
Page 2 of 156
***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: 10151047 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/17/2020
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140852
Page 3 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151047]
2.Birth Date: /1990
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):ASIAN
6.Racial Designation:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0140853
Page 4 of 156
***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: 10151047 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/17/2020
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140854
Page 5 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140855
Page 6 of 156
***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: 10151047 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/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140856
Page 7 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Migraines]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140857
Page 8 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [145.0]
3.Unit: LB
4.Height: [62.0]
5.Unit: in
6.Body Mass Index: [26.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140858
Page 9 of 156
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/17/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140859
Page 10 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [53307]
3.Randomization Group: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140860
Page 11 of 156
***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: 10151047 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/17/2020
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 [BLD039]
5.bSample ID [BLD03B]
5.cSample ID [BM8FD3]
5.dSample ID [BM8FD4]
5.eSample ID [BM8FD5]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140861
Page 12 of 156
***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: 10151047 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/17/2020
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 [BM8FCY]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140862
Page 13 of 156
***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: 10151047 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/17/2020 17:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140863
Page 14 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140864
Page 15 of 156
***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: 10151047 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/9/2020
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140865
Page 16 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140866
Page 17 of 156
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/9/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140867
Page 18 of 156
***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: 10151047 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/9/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9J0S]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140868
Page 19 of 156
***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: 10151047 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/9/2020 15:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140869
Page 20 of 156
***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: 10151047 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/7/2020
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140870
Page 21 of 156
***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: 10151047 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/7/2020
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 [BP9HLG]
5.bSample ID [BLD0NY]
5.cSample ID [BLD0NZ]
5.dSample ID [BLD0P5]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140871
Page 22 of 156
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140872
Page 23 of 156
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140873
Page 24 of 156
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140874
Page 25 of 156
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140875
Page 26 of 156
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140876
Page 27 of 156
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140877
Page 28 of 156
***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: 10151047 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:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140878
Page 29 of 156
***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: 10151047 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: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140879
Page 30 of 156
***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: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140880
Page 31 of 156
***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: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140881
Page 32 of 156
***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: 10151047 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?
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140882
Page 33 of 156
***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: 10151047 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:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140883
Page 34 of 156
***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: 10151047 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:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140884
Page 35 of 156
***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: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140885
Page 36 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140886
Page 37 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140887
Page 38 of 156
***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: 10151047 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/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140888
Page 39 of 156
***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: 10151047 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: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140889
Page 40 of 156
***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: 10151047 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:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140890
Page 41 of 156
***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: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140891
Page 42 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Id
entifie
rAdverse EventStart Da
teIs the Adverse E
vent Still Ongoin
gForm Insta
nce
 1.ADVERS
E EVEN
T 1 Right corneal irritation  Aug/17/2
020 22:5
4 NO
End Date Time:
Aug/20/2020 U
NK:UNK
 Repeating
Pages
 2.ADVERS
E EVEN
T 2 SIRVA - shoulder injury r
elated to vaccine administ
ration Sep/9/20
20 18:00 NO
End Date Time:
Feb/8/2021 UN
K:UNK
 Repeating
Pages
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140892
Page 43 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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)[Right corneal irritation]
4.Start Date Time: Aug/17/2020 22:54
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/20/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140893
Page 44 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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:
[Contact lens wear]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140894
Page 45 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140895
Page 46 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[SIRVA - shoulder injury related to vaccine administration]
4.Start Date Time: Sep/9/2020 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/8/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140896
Page 47 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140897
Page 48 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020358753]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140898
Page 49 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140899
Page 50 of 156
***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: 10151047 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[ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140900
Page 51 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140901
Page 52 of 156
***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: 10151047 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: //
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140902
Page 53 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140903
Page 54 of 156
***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: 10151047 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?
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140904
Page 55 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140905
Page 56 of 156
***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: 10151047 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?
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140906
Page 57 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140907
Page 58 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140908
Page 59 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140909
Page 60 of 156
***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: 10151047 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:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140910
Page 61 of 156
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140911
Page 62 of 156
***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: 10151047 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?
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140912
Page 63 of 156
***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: 10151047 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: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140913
Page 64 of 156
***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: 10151047 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: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140914
Page 65 of 156
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140915
Page 66 of 156
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140916
Page 67 of 156
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140917
Page 68 of 156
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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 [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140918
Page 69 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140919
Page 70 of 156
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140920
Page 71 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140921
Page 72 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140922
Page 73 of 156
***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: 10151047 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: [ ]
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140923
Page 74 of 156
***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: 10151047 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/7/2020
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140924
Page 75 of 156
***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: 10151047 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
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140925
Page 76 of 156
***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: 10151047 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-12-2021 08:34:46 (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.
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140926
Page 77 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-17-2020 18:13:44 (UTC-05:00)
Eastern Time (US & Canada)Taylor
Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140927
Page 78 of 156
***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: 10151047 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-12-2021 08:34:46 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
Taylor
Stannard N/A Mar-08-2021 13:39:25 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Jan-21-2021 19:49:01 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140928
Page 79 of 156
***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: 10151047 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 Dec-23-2020 14:10:27 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Oct-20-2020 20:43:51 (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.
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140929
Page 80 of 156
***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: 10151047 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-17-2020
18:13:14
(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-17-2020
18:13:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140930
Page 81 of 156
***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: 10151047 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-17-2020
18:13:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/17/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140931
Page 82 of 156
***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: 10151047 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-17-2020
18:13:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10151047Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020
18:13:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1990Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020
18:13:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0140932
Page 83 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020
18:13:28
(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-17-2020
18:13:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ASIANInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140933
Page 84 of 156
***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: 10151047 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-17-2020
18:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140934
Page 85 of 156
***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: 10151047 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-17-2020
18:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020
18:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020
18:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140935
Page 86 of 156
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020
18:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Migraine
s
Start Date: UNK/U
NK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020
18:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
18:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
MigrainesInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140936
Page 87 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.a Start Date:
Date Location User Value Reason
Aug-17-2020
18:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-17-2020
18:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140937
Page 88 of 156
***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: 10151047 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-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
145.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140938
Page 89 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
62.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020
18:15:57
(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-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.5Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Id
entifier::1
Temperat
ure:98.2Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140939
Page 90 of 156
***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: 10151047 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-17-2020
18:15:57
(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-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140940
Page 91 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020
18:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140941
Page 92 of 156
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140942
Page 93 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140943
Page 94 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-17-2020
18:16:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140944
Page 95 of 156
***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: 10151047 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-17-2020
18:16:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020
18:16:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
53307Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140945
Page 96 of 156
***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: 10151047 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-17-2020
19:49:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020
19:49:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020
19:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-17-2020
19:49:17
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140946
Page 97 of 156
***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: 10151047 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-17-2020
19:49:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020
19:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BLD03
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
19:49:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD039Initial Entry
5.b
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140947
Page 98 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-17-2020
19:49:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD03
BInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020
19:49:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD03BInitial Entry
5.c
Date Location User Value Reason
Aug-17-2020
19:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8FD
3Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140948
Page 99 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Aug-17-2020
19:54:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FD3Initial Entry
5.d
Date Location User Value Reason
Aug-17-2020
19:54:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8FD
4Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-17-2020
19:54:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FD4Initial Entry
5.e
Date Location User Value Reason
Aug-17-2020
19:54:29ACV0PFEINFP6000  Taylor
StannardData Entry:
Sample I BM8FDInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140949
Page 100 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) D: 5
5.e Sample ID
Date Location User Value Reason
Aug-17-2020
19:54:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FD5Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140950
Page 101 of 156
***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: 10151047 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-17-2020
19:55:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020
19:55:02
(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-17-2020
19:55:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140951
Page 102 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020
19:54:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BM8FC
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020
19:54:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FCYInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140952
Page 103 of 156
***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: 10151047 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-17-2020
18:16:52
(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-17-2020
18:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020
18:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140953
Page 104 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020
18:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020 17:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020
18:16:52
(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-17-2020
18:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020
18:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140954
Page 105 of 156
***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: 10151047 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-17-2020
18:16:52
(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-17-2020
18:16:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140955
Page 106 of 156
***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: 10151047 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-17-2020
18:16:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO - REACTOGEN
ICITY E-DIARY N
OT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140956
Page 107 of 156
***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: 10151047 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-09-2020
17:14:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/9/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140957
Page 108 of 156
***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: 10151047 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-09-2020
17:14:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020
17:14:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Id
entifier::1
Temperatu
re:97.5
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020
17:14:47
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140958
Page 109 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-09-2020
17:14:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020
17:14:47
(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-09-2020
17:14:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140959
Page 110 of 156
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140960
Page 111 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140961
Page 112 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-09-2020
17:14:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140962
Page 113 of 156
***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: 10151047 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-09-2020
19:14:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
19:14:42
(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-09-2020
19:14:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
19:14:42
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140963
Page 114 of 156
***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: 10151047 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-09-2020
19:14:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
19:14:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID
:BP9J0
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
19:14:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9J0SInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140964
Page 115 of 156
***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: 10151047 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-09-2020
17:15:27
(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-09-2020
17:15:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
17:15:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140965
Page 116 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-09-2020
17:15:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/9/2020 15:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020
17:15:27
(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-09-2020
17:15:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
17:15:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140966
Page 117 of 156
***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: 10151047 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-09-2020
17:15:27
(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-09-2020
17:15:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140967
Page 118 of 156
***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: 10151047 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-07-2020
13:29:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/7/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140968
Page 119 of 156
***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: 10151047 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-09-2020
11:21:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020
11:21:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020
11:21:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-09-2020
11:21:41
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140969
Page 120 of 156
***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: 10151047 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-09-2020
11:21:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collectio
n:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020
11:21:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BP9HL
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-09-2020
11:21:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HLGInitial Entry
5.b
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140970
Page 121 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-09-2020
12:01:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD0N
YInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-09-2020
12:01:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0NYInitial Entry
5.c
Date Location User Value Reason
Oct-09-2020
12:01:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD0N
ZInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140971
Page 122 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-09-2020
12:01:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0NZInitial Entry
5.d
Date Location User Value Reason
Oct-09-2020
12:08:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample I
D:BLD0P
5Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-09-2020
12:08:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0P5Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140972
Page 123 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-09-2020
12:08:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-09-2020
12:08:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020
12:08:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140973
Page 124 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140974
Page 125 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140975
Page 126 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-11-2020
11:35:22
(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
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Right corneal irritati
onInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140976
Page 127 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/17/2020 22:54Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Aug/20/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140977
Page 128 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), th
is event is due to:
OTHER
If Other, specify:
Contact lens w
earInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140978
Page 129 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-11-2020
11:35:22
(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
Sep-11-2020
11:35:22
(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
Sep-11-2020
11:35:22ACV0PFEINFP6000  Taylor
StannardData Entry:
RECOVERED/RESInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140979
Page 130 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)(pfe.tstannard) OLVED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-11-2020
11:35:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140980
Page 131 of 156
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-08-2020
22:13:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3:
ClosedResponse satisfies query
Oct-08-2020 ACV0PFEINFP6000  auto query Query 3: New Information
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140981
Page 132 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
15:45:27
(UTC-05:00)
Eastern Time
(US &
Canada)(autoquery) Answered
Oct-08-2020
15:45:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Ent
ry:
SIRVA - s
houlder in
jury relate
d to vacci
ne admini
strationNew Information
Oct-08-2020
07:16:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3:
OpenedSAE
RECON:AER#2020358753
term was updated back to
SIRVA in Safety database.
Per Clinical comment 's per
records, immune mediated
brachual was ruled out .
Please confirm and update
term accordingly.
Oct-01-2020
14:52:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Ent
ry:
Immune-
mediated
brachial p
lexus neu
ropathyUpdated from SIRVA -
shoulder injury related to
vaccine administration -
upper deltoid, per query
Sep-22-2020
17:30:41ACV0PFEINFP6000  Charu
SabharwalQuery 2:
ClosedWill close for now but
additional queries may be
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140982
Page 133 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time
(US &
Canada)(pfe.sabhac) requested for SAE
narrative clarification
Sep-21-2020
12:35:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2:
AnsweredTranscription Error
Sep-21-2020
12:35:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Ent
ry:
SIRVA - s
houlder in
jury relate
d to vacci
ne admini
stration -
upper delt
oidTranscription Error
Sep-19-2020
12:14:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Charu
Sabharwal
(pfe.sabhac)Query 2:
OpenedClinical_as per the SAE
narrative "She [subject]
noted that the band-aid was
very high on her arm."
Please submit a follow-up
SAE/AER 2020358753
with the location of the
injection in the deltoid re:
upper or lower portion of
the deltoid.
Sep-18-2020 ACV0PFEINFP6000  Cavin van Query 1: Response satisfies query
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140983
Page 134 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
04:33:43
(UTC-05:00)
Eastern Time
(US &
Canada)Schalkwyk
(pfe.vanscc01)Closed
Sep-17-2020
12:52:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription Error
Sep-17-2020
12:52:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Ent
ry:
SIRVA - s
houlder in
jury relate
d to vacci
ne admini
strationTranscription Error
Sep-17-2020
11:58:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 1:
OpenedDM: A trailing space is
identified. To avoid
processing errors, please
remove the identified
character by deleting the
entry and re-entering the
data (without using copy
and paste).
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Ent
ry:
SIRVA - s
houlder inInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140984
Page 135 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US &
Canada)jury relate
d to vacci
ne admini
stration
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020
15:54:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 2: Closed Response
satisfies query
Sep-18-2020
15:53:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answe
redAnswer Auto
Query
Sep-18-2020
15:53:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data Entry:
Sep/9/2020 18:0
0approximate
time
Sep-18-2020
15:16:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 2: Reissu
ed:OpenedIf AE occurs on
the day of
vaccination,
then a full start
date and time is
expected.
Unknown
date/time is
unacceptable. If
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140985
Page 136 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
actual time is
unknown,
record the
approximate
time. Please
review and
update as
appropriate.
Sep-18-2020
11:51:19
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 2: Answe
redDid not report
exact time,
happened after
injection
Sep-17-2020
12:52:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dFor AE SIRVA
- shoulder
injury related to
vaccine
administration:
Start Date is the
same as a
Vaccination
Date, but time
is not provided.
Please review
and update as
appropriate.
Sep-17-2020
05:54:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response
satisfies query
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140986
Page 137 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020
10:41:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 1: Answe
redAE started after
the vaccination.
Sep-16-2020
09:08:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Pramod Margaj
(pfe.margap03)Query 1: Reissu
ed:OpenedDM 1: Thanks
for your
response.
Please confirm
if AE started
before or after
Vaccination.
Sep-15-2020
16:41:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 1: Answe
redReported "late
in the evening"
did not specify
an exact time.
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opene
dFor AE SIRVA
- shoulder
injury related to
vaccine
administration :
Start Date is the
same as a
Vaccination
Date, but time
is not provided.
Please review
and update as
appropriate.
Sep-15-2020 ACV0PFEINFP6000  Taylor Stannard Data Entry: Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140987
Page 138 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
16:40:20
(UTC-05:00)
Eastern Time
(US & Canada)(pfe.tstannard) Sep/9/2020 UN
K:UNK
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
14:15:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
Liau
(pfe.liaukf)Query 2: Closed Response
satisfies query
Mar-08-2021
13:39:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Feb/8/2021 UN
K:UNKNew
Information
Mar-08-2021
13:36:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 2: Answere
dAE is ongoing
Mar-02-2021
04:57:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
Liau
(pfe.liaukf)Query 2: Opened GPD CLIN:
Please confirm
if the subject's
AE is still
ongoing else
provide end
date as
applicable.
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140988
Page 139 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-20-2020
20:56:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Xiaoxia Liu
(pfe.xiaoxl)Query 1: Closed Response
satisfies query
Oct-16-2020
09:46:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answere
dThe SIRVA is
continuing for
this subject as
of their last
visit.
Oct-15-2020
20:09:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Xiaoxia Liu
(pfe.xiaoxl)Query 1: Opened ClinQuery:
SIRVA -
shoulder injury
related to
vaccine
administration
is currently
marked as
ongoing (start
date >28 days
ago), however
this appears to
be a temporary
event related to
study treatment.
Please provide
an end date or
clarification.
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140989
Page 140 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
& Canada)
6. Toxicity Grade:
Date Location User Value Reason
Oct-20-2020
12:41:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Brent Spears
(pfe.spearj09)Query 1: Closed Response
satisfies query
Oct-14-2020
11:31:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-14-2020
11:31:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
3Changed
Information
Oct-12-2020
18:40:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Brent Spears
(pfe.spearj09)Query 1: Reissued:
OpenedPer
investigator
source note for
encounter on
07Oct2020,
max toxicity
grade was
documented as
severe (3).
Please
reconcile
eCRF and
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140990
Page 141 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
source.
Oct-08-2020
15:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Waiting for
source to be
updated.
Oct-08-2020
15:47:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry: Waiting for
source to be
updated.
Oct-06-2020
14:10:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Brent Spears
(pfe.spearj09)Query 1: Opened Toxicity grade
not
documented in
source. Please
confirm data is
correct.
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140991
Page 142 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-08-2020
08:19:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3:
ClosedPer Clinical comment
Safety and CDB ; as per
records, immune mediated
brachual was ruled out -
deletion of immune
mediated plxus neuropathy
and SIRVA should be
reported as per medical
records- Query issued in
term
Oct-02-2020
08:02:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3:
Reissued:
OpenedSAE RECON 1: Term was
updated.However,SIRVA
and immune-mediated
brachial plexus neuropathy
was reported as 2 separate
events in SDB. Please
confirm if these are indeed
separate events and to be
added in AE CRF as
separate entries.
Oct-01-2020
14:52:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 3:
AnsweredChanged data per query
Oct-01-2020
06:44:09
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3:
OpenedSAE
RECON:AER#2020358753
immune-mediated brachial
plexus neuropathy(onset
date:09Sep2020)was
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140992
Page 143 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Canada) reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-18-2020
05:38:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2:
DeletedClose Auto Query
Sep-17-2020
12:52:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2:
CandidateFor AE SIRVA - shoulder
injury related to vaccine
administration: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140993
Page 144 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 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
Sep-17-2020
11:18:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Sep-16-2020
10:55:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answer
edConfirmed
seriousness,
already reported
to pfizer.
Sep-16-2020
08:48:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:SIRVA
-shoulder injury
related to
vaccine
administration
(Onset
date:09Sep2020)
is not reported
on SAE Report
Form but
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140994
Page 145 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
marked serious
on AE CRF.
Confirm
seriousness and
report to Pfizer.If
this event is not
serious,
downgrade the
event in Inform
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candid
ateFor AE SIRVA -
shoulder injury
related to
vaccine
administration :
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this seriousInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140995
Page 146 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
event result in
death?
NO
Did this serious
event require or
prolong hospita
lization?
NO
Did this serious
event result in
persistent or sig
nificant disabili
ty/incapacity?
NO
Is this serious e
vent life threate
ning?
NO
Other medicall
y important seri
ous event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140996
Page 147 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020
16:40:20
(UTC-05:00)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140997
Page 148 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time (US
& Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020
16:40:20
(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
Mar-11-2021
05:38:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2:
ClosedSDB updated
Mar-09-2021
15:29:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 2:
Reissued
:Candida
tePending SDB update
Mar-09-2021
11:07:39
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 2:
Answere
dFaxed update on 9mar2021
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140998
Page 149 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US &
Canada)
Mar-09-2021
05:17:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2:
OpenedSAE
RECON:AER#2020358753
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/Resolving in
Safety database. Please
confirm correct outcome. If
safety update is required,
please submit a follow-up
form.
Mar-08-2021
13:39:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
ClosedClose Auto Query
Mar-08-2021
13:39:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data En
try:
RECOV
ERED/R
ESOLVE
DNew Information
Mar-08-2021
13:39:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
OpenedFor AE SIRVA - shoulder
injury related to vaccine
administration: Response to
"What was the outcome of
this adverse event?" is
'Recovering/Resolving' but
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140999
Page 150 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
AE End Date/Time is
present.
Sep-15-2020
16:40:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data En
try:
RECOV
ERING/
RESOLV
INGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-15-2020
16:40:20
(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
Sep-18-2020
05:38:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020358753Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141000
Page 151 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020
14:10:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141001
Page 152 of 156
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-23-2020
14:10:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing
to return for Vaccina
tion 3
Participant is:
eligible and NOT
confirmed to hav
e received only pl
acebo at Vaccinat
ion 1/2Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141002
Page 153 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-23-2020
14:10:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-23-2020
14:10:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITIO
NAL VACCINATIO
NInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141003
Page 154 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-09-2020
12:08:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-17-2020
18:16:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-17-2020
18:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-09-2020
12:08:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-17-2020
18:16:25ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141004
Page 155 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-17-2020
18:13:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141005
Page 156 of 156
***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: 10151047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020
20:43:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Elizabeth
Barnett
(pfe.ebarnett)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fe4\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141006