125742 S1 M5 CRF c4591001 1015 10151238

Document text

Page 1 of 435
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141853
Page 2 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/2/2020
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141854
Page 3 of 435
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151238]
2.Birth Date: /1945
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0141855
Page 4 of 435
***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: 10151238 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/2/2020
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141856
Page 5 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141857
Page 6 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141858
Page 7 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10151238 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:[Type 2 Diabetes]
Start Date: UNK/UNK/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Alcoholic cirrhosis]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prostate cancer]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2003
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141859
Page 8 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/2012
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep Apnea]
Start Date: UNK/UNK/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2013
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic Neuropathy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Congestive Heart Failure]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141860
Page 9 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Generalized anxiety disorder]
Start Date: UNK/UNK/2005
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2000
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/1990
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Excessive urination]
Start Date: UNK/UNK/1955
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIV]
Start Date: UNK/UNK/1991
Ongoing: YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141861
Page 10 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[COPD]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141862
Page 11 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is known to be HIV POSITIVE
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141863
Page 12 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY
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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [QUEST CHANTILLY, QUEST DIAGNOSTIC NICHOLS INSTITUTE,CLIA
49D0221801,14225 Newbrook Drive,Chantilly VA 20151]
3.Collection Date: Sep/17/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [2124]
Test: HIV RNA (Ultrasensitive)
Result: [<20]
LNMT Low
[20]
High
[10000000]
Unit
/mL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141864
Page 13 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [SUNQUEST, BOSTON MEDICAL CENTER LABORATORY, CLIA
22D0867404, One Boston Medical Center Place,Boston MA 02118]
3.Collection Date: Sep/17/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [4722]
Test: CD4_PX4722
Result: [0.666]
LNMT Low
[.430]
High
[1.185]
Unit
10^3/mm3
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141865
Page 14 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
2.Weight: [208.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [34.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141866
Page 15 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/2/2020
2.Randomization Number: [266982]
3.Randomization Group: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141867
Page 16 of 435
***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: 10151238 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/2/2020
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 [BLD0KV]
5.bSample ID [BLD0KP]
5.cSample ID [BLD0KR ]
5.dSample ID [BP9HK0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141868
Page 17 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BP9HJV]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141869
Page 18 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/2/2020 12:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141870
Page 19 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141871
Page 20 of 435
***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: 10151238 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/27/2020
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141872
Page 21 of 435
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141873
Page 22 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141874
Page 23 of 435
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141875
Page 24 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BP9HTX]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141876
Page 25 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/27/2020 13:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141877
Page 26 of 435
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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 Nov/24/2020
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141878
Page 27 of 435
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141879
Page 28 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141880
Page 29 of 435
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
HIV RNA (Ultrasensitive)
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141881
Page 30 of 435
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
CD4_PX4722
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141882
Page 31 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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:
Nov/24/2020
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 [BSH19C]
5.bSample ID [BRFKHP]
5.cSample ID [BSH19D]
5.dSample ID [BSH19F]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141883
Page 32 of 435
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141884
Page 33 of 435
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
HIV RNA (Ultrasensitive)
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141885
Page 34 of 435
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
CD4_PX4722
Result: Not Applicable
[ ]Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141886
Page 35 of 435
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141887
Page 36 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141888
Page 37 of 435
***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: 10151238 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 [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141889
Page 38 of 435
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141890
Page 39 of 435
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141891
Page 40 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141892
Page 41 of 435
***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: 10151238 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 [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141893
Page 42 of 435
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: LAB CHEMISTRY
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141894
Page 43 of 435
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: LABORATORY DATA - HEMATOLOGY
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141895
Page 44 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141896
Page 45 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/20/2021
2.Date of First Symptom Started: Jan/20/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/26/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141897
Page 46 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
5.bSymptoms - Other Text: [Chest tightness]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141898
Page 47 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/20/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141899
Page 48 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/20/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: BIOFIRE COVID-19 TEST
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141900
Page 49 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Swab not collected - study team was no aware of symptoms]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141901
Page 50 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Swab not collected - study team was no aware of symptoms]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141902
Page 51 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[3]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[4]
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141903
Page 52 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/20/2021  NO
Discharge Date:
Jan/23/2021
 Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141904
Page 53 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/20/2021
4.Ongoing? NO
Discharge Date:
Jan/23/2021
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141905
Page 54 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatment TreatmentStart D
ateForm Instan
ce
 1.1  YES  HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Jan/20/
2021 Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141906
Page 55 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Jan/20/2021
6.Ongoing? YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141907
Page 56 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Pneumonia]
Date of Diagnosis:
Jan/20/2021
3.Toxicity Grade: 3
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141908
Page 57 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141909
Page 58 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141910
Page 59 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for
Lab TestVendor NameCollecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
 1.CLINICAL
CHEMISTR
Y BOSTON MEDICAL
CENTER LABORATO
RY
CLIA 22D0867404
One Boston Medical C
enter Place
Boston MA 02118 Jan/20/2
021 BLOO
D Sponsor-Defi
ned Identifie
rTest:Res
ult:
329  C Reactive Prote
in_PX329 .8 
30  Alanine Aminotr
ansferase_PX30 [ ] 
28  Aspartate Amino
transferase_PX2
8 [ ] 
35  Alkaline Phosph
atase_PX35 104 
21  Bilirubin_PX21  .9 
47  Blood Urea Nitr
ogen_PX47 22 
48  Creatinine_PX4
8 1.79
 Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141911
Page 60 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [BOSTON MEDICAL CENTER LABORATORY
CLIA 22D0867404
One Boston Medical Center Place
Boston MA 02118]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [.8]
Not Done:
LNMT Low
[.68]
High
[.86]
Unit
g/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141912
Page 61 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [104]
Not Done:
LNMT Low
[25]
High
[100]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [.9]
Not Done:
LNMT Low
[.3]
High
[1.2]
Unit
mg/dL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141913
Page 62 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [22]
Not Done:
LNMT Low
[7]
High
[25]
Unit
g/L
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.79]
Not Done:
LNMT Low
[.7]
High
[1.3]
Unit
mg/dL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141914
Page 63 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category fo
r Lab TestVendor Name (DERIVE
D)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.HEMATOL
OGY BOSTON MEDICAL CE
NTER LABORATORY
CLIA 22D0867404
One Boston Medical Cent
er Place
Boston MA 02118 Jan/20/2
021 BLOOD Sponsor-Defi
ned IdentifierTest:Res
ult:
1  Hemoglobi
n_PX1 13.6
 
2  Hematocrit
_PX2 43.4
 
3  Erythrocyte
s_PX3 [ ] 
5  Platelets_P
X5 238 
7  Leukocytes
_PX7 [ ] 
608  Neutrophils
_PX608 16.7
 
609  Eosinophils
_PX609 0 
612  Monocytes
_PX612 9 
610  Basophils_
PX610 0 
611  Lymphocyt
es_PX611 10 Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141915
Page 64 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [BOSTON MEDICAL CENTER LABORATORY
CLIA 22D0867404
One Boston Medical Center Place
Boston MA 02118]
3.Collection Date: Jan/20/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.6]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [43.4]
Not Done:
LNMT Low
[40]
High
[51]
Unit
%
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141916
Page 65 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [238]
Not Done:
LNMT Low
[150]
High
[400]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141917
Page 66 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [16.7]
Not Done:
LNMT Low
[4]
High
[11]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0]
Not Done:
LNMT Low
[0]
High
[7]
Unit
%
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [9]
Not Done:
LNMT Low
[4]
High
[13]
Unit
%
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141918
Page 67 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0]
Not Done:
LNMT Low
[0]
High
[1]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [10]
Not Done:
LNMT Low
[15]
High
[54]
Unit
%
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141919
Page 68 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 1.Jan/20/2021 Record Identifier: Systolic: Diastolic:
1  179  72 Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141920
Page 69 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 2. DELETED Jan/20/2021 Record Identifier: Systolic: Diastolic:
1  113  58 Repeating Pages
 3. DELETED Jan/20/2021 Record Identifier: Systolic: Diastolic:
1  179  72 Repeating Pages
 4. Jan/21/2021 Record Identifier: Systolic: Diastolic:
1  138  75 Repeating Pages
 5. DELETED Jan/21/2021 Record Identifier: Systolic: Diastolic:
1  129  66 Repeating Pages
 6. DELETED Jan/21/2021 Record Identifier: Systolic: Diastolic:
1  137  67 Repeating Pages
 7. Jan/22/2021 Record Identifier: Systolic: Diastolic:
1  158  78 Repeating Pages
 8. DELETED Jan/22/2021 Record Identifier: Systolic: Diastolic:
1  157  74 Repeating Pages
 9. DELETED Jan/22/2021 Record Identifier: Systolic: Diastolic:
1  153  74 Repeating Pages
 10. Jan/23/2021 Record Identifier: Systolic: Diastolic:
1  161  83 Repeating Pages
 11. DELETED Jan/23/2021 Record Identifier: Systolic: Diastolic:
1  147  77 Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141921
Page 70 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [179]
Diastolic: [72]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [105]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141922
Page 71 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [113]
Diastolic: [58]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [105]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141923
Page 72 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [179]
Diastolic: [72]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [100]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141924
Page 73 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [138]
Diastolic: [75]
Respiratory Rate in
respirations/minute:[23]
Heart Rate in beats/minute: [108]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141925
Page 74 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [129]
Diastolic: [66]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [108]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141926
Page 75 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [137]
Diastolic: [67]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [103]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141927
Page 76 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/22/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [158]
Diastolic: [78]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [100]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141928
Page 77 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/22/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [157]
Diastolic: [74]
Respiratory Rate in
respirations/minute:[22]
Heart Rate in beats/minute: [100]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141929
Page 78 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/22/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [153]
Diastolic: [74]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [96]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141930
Page 79 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/23/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [161]
Diastolic: [83]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [98]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141931
Page 80 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/23/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [147]
Diastolic: [77]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [98]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141932
Page 81 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 1. DELETED Jan/20/2021 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141933
Page 82 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Date: Vital Signs Details Form Instance
 2. DELETED Jan/20/2021 Record Identifier: Oxygen Saturation
1  93.0 Repeating Pages
 3. Jan/20/2021 Record Identifier: Oxygen Saturation
1  92.0 Repeating Pages
 4. DELETED Jan/21/2021 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
 5. Jan/21/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
 6. DELETED Jan/21/2021 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
 7. DELETED Jan/22/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
 8. Jan/22/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141934
Page 83 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141935
Page 84 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141936
Page 85 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/20/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [92.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141937
Page 86 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141938
Page 87 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141939
Page 88 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/21/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141940
Page 89 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/22/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141941
Page 90 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/22/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141942
Page 91 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141943
Page 92 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141944
Page 93 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141945
Page 94 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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.Start Date: //
6.Ongoing?
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141946
Page 95 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Jan/20/2021  CHEST  X-RAY  NORMAL  Repeating Pages
 2.Jan/20/2021  HEAD  CT SCAN  NORMAL  Repeating Pages
 3.Jan/21/2021  CHEST  X-RAY  NORMAL  Repeating Pages
 4.Jan/20/2021  OTHER
If other, specify:
Abdomen
 ULTRASOUND  NORMAL  Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141947
Page 96 of 435
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141948
Page 97 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: HEAD
3.Type of Imaging Exam: CT SCAN
4.Assessment: NORMAL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141949
Page 98 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/21/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141950
Page 99 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/20/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: OTHER
If other, specify:
[Abdomen]
3.Type of Imaging Exam: ULTRASOUND
4.Assessment: NORMAL
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141951
Page 100 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/10/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141952
Page 101 of 435
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR70H6]
5.bSample ID [BSH1M5]
5.cSample ID [BSH1M4]
5.dSample ID [BSH1M3]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141953
Page 102 of 435
***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: 10151238 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:
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141954
Page 103 of 435
***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: 10151238 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 [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141955
Page 104 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141956
Page 105 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141957
Page 106 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identif
ierAdverse Eve
ntStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Pneumonia  Jan/20/2021 UNK:
UNK NO
End Date Time:
Jan/27/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Peripheral ede
ma Feb/3/2021 UNK:U
NK NO
End Date Time:
Mar/5/2021 UNK:UNK
 Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141958
Page 107 of 435
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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)[Pneumonia]
4.Start Date Time: Jan/20/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/27/2021 UNK:UNK
6.Toxicity Grade: 3
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?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141959
Page 108 of 435
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
[Un-related to vaccine]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021082462]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141960
Page 109 of 435
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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)[Peripheral edema]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/5/2021 UNK:UNK
6.Toxicity Grade: 2
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:
[Exisiting neuropathy]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
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Page 110 of 435
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141962
Page 111 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141963
Page 112 of 435
***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: 10151238 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[ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141964
Page 113 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141965
Page 114 of 435
***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: 10151238 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: //
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
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Page 115 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141967
Page 116 of 435
***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: 10151238 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?
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141968
Page 117 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141969
Page 118 of 435
***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: 10151238 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?
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141970
Page 119 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141971
Page 120 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141972
Page 121 of 435
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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
:Nov/24/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141973
Page 122 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141974
Page 123 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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:
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141975
Page 124 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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?
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141976
Page 125 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141977
Page 126 of 435
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141978
Page 127 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141979
Page 128 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141980
Page 129 of 435
***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: 10151238 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 [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141981
Page 130 of 435
***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: 10151238 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 [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141982
Page 131 of 435
***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: 10151238 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: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141983
Page 132 of 435
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141984
Page 133 of 435
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141985
Page 134 of 435
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141986
Page 135 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141987
Page 136 of 435
***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: 10151238 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: [ ]
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141988
Page 137 of 435
***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: 10151238 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 Nov/24/2020
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141989
Page 138 of 435
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141990
Page 139 of 435
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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 08:41:35 (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.
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141991
Page 140 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-02-2020 14:49:11 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141992
Page 141 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141993
Page 142 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141994
Page 143 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.aNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141995
Page 144 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.bNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141996
Page 145 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.cNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141997
Page 146 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.dNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141998
Page 147 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.eNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0141999
Page 148 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2 fNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142000
Page 149 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2.gNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142001
Page 150 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2 hNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142002
Page 151 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142003
Page 152 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142004
Page 153 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142005
Page 154 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.bNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142006
Page 155 of 435
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.cNov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Diary not activated for vaccine one, protocol
deviation filed.
Not Done
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142007
Page 156 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142008
Page 157 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142009
Page 158 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142010
Page 159 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142011
Page 160 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142012
Page 161 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aDec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142013
Page 162 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aDec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142014
Page 163 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aDec-01-2020 10:04:24 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142015
Page 164 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormDec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
FormDec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
FormDec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142016
Page 165 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Dec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
1Dec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
1Dec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142017
Page 166 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Dec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
2Dec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
2Dec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142018
Page 167 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Dec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
3Dec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
3Dec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142019
Page 168 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Dec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
4Dec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
4Dec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142020
Page 169 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aDec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
5.aDec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
5.aDec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142021
Page 170 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aDec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
5.aDec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
5.aDec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142022
Page 171 of 435
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aDec-02-2020 13:34:43 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
5.aDec-02-2020 13:34:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)
5.aDec-01-2020 10:05:17 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142023
Page 172 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142024
Page 173 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142025
Page 174 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142026
Page 175 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142027
Page 176 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142028
Page 177 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aMar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142029
Page 178 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aMar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142030
Page 179 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LAB CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aMar-10-2021 14:32:44 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142031
Page 180 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142032
Page 181 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142033
Page 182 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142034
Page 183 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142035
Page 184 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142036
Page 185 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aMar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142037
Page 186 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aMar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142038
Page 187 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: LABORATORY DATA - HEMATOLOGY - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aMar-10-2021 14:33:08 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142039
Page 188 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormMar-10-2021 14:33:57 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142040
Page 189 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Mar-10-2021 14:33:57 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142041
Page 190 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Mar-10-2021 14:33:57 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142042
Page 191 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Mar-10-2021 14:33:57 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142043
Page 192 of 435
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Mar-10-2021 14:33:57 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142044
Page 193 of 435
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 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 08:41:35 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Taylor Stannard  N/A Jan-29-2021 13:00:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Jan-21-2021 08:20:35 (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 Nov-30-2020 12:41:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142045
Page 194 of 435
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Stephen Pelton  Approved Nov-17-2020 16:59:40 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenPelton, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Taylor Stannard  N/A Nov-11-2020 15:33:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Nov-11-2020 13:45:23 (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.
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142046
Page 195 of 435
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-02-2020 14:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-02-2020 14:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142047
Page 196 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-02-2020 14:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/2/2020Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142048
Page 197 of 435
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-02-2020 14:48:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10151238Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-02-2020 14:48:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1945Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-02-2020 14:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-02-2020 14:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-02-2020 14:48:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0142049
Page 198 of 435
***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: 10151238 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-02-2020 14:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/2/2020Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142050
Page 199 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-02-2020 14:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 14:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 14:49:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142051
Page 200 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Oct-02-2020 14:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Type 2 Diabe
tes
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:52:23
(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
Oct-02-2020 14:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Type 2 DiabetesInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-02-2020 14:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-02-2020 14:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142052
Page 201 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b
Date Location User Value Reason
Oct-07-2020 14:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Alcoholic cir
rhosis
Start Date: UNK/UNK/2
015
Ongoing: YESNew Information
Oct-02-2020 14:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Cirrhosis
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142053
Page 202 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020
16:25:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 1:
ClosedDiscrepancy
has been
closed.
Oct-07-2020
14:48:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query 1:
Answere
dNew
Information
Oct-07-2020
14:48:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data En
try:
Alcoholi
c cirrhos
isNew
Information
Oct-07-2020
09:43:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Jeffrey Signora
TMSQUERY
(pfe.signoj01_tmsquery)Query 1:
Reissued
:OpenedCoding cannot
take place with
the term as is.
Please
follow-up with
the participant
to further
specify
Cirrhosis.
Oct-05-2020
10:10:40
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 1:
Answere
dParticipant did
not specify
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142054
Page 203 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Canada)
Oct-02-2020
16:21:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle
(pfe.PFETMS)Query 1:
OpenedClarify
CIRRHOSIS
as follow...Are
you reporting
ALCOHOLIC
CIRRHOSIS
or the term
BILIARY
CIRRHOSIS?
Or others? If
so, please edit
it to such.
Otherwise,
clarify. Thank
you.
Oct-02-2020
14:52:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data En
try:
Cirrhosi
sInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-02-2020 14:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-02-2020 14:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-02-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142055
Page 204 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History
Term:Prostate cancer
Start Date: UNK/UNK/200
2
Ongoing: NO
End Date:
UNK/UNK/
2003
1.c Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Prostate cancerInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-02-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2002Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-02-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.d
Date Location User Value Reason
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142056
Page 205 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-02-2020 14:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Hypothyroidi
sm
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HypothyroidismInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-02-2020 14:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2002Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-02-2020 14:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-02-2020 14:54:04
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 5Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142057
Page 206 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) :
Medical History T
erm:Asthma
Start Date: UNK/UNK/2
012
Ongoing: YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142058
Page 207 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:54:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-10-2021 12:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-04-2021 11:35:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 2: Answered Added to SAE.
Faxed on 4feb2021
Feb-02-2021 15:36:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-02-2021 09:53:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Added COPD to
Med Hx
Feb-01-2021 08:25:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical Med Hx
includes asthma
since 2012; however
SAE report for
Pneumonia
(#2021082462) does
not include this Med
Hx condition. Please
review for safety
relevance, & update
SAE Med Hx if
appropriate
Feb-01-2021 08:23:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical On review
of the SAE report
for Pneumonia
(#2021082462),
medical history of
COPD was reported
(2009 onset), yet it
does not appear in
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142059
Page 208 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
the CRF. Please
review for clinical
relevance to safety
event and update
Med Hx log CRF if
appropriate.
Oct-02-2020 14:54:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
AsthmaInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-02-2020 14:54:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2012Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-02-2020 14:54:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-02-2020 14:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Sleep Apnea
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142060
Page 209 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.f Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sleep ApneaInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-02-2020 14:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-02-2020 14:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-02-2020 14:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142061
Page 210 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.g Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HypertensionInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-02-2020 14:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-02-2020 14:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-06-2020 10:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Diabetic Neur
opathy
Start Date: UNK/UNK/2
010
Ongoing: YESChanged
Information
Oct-02-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe 8Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142062
Page 211 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
r:
Medical History
Term:Neuropathy
Start Date: UNK/UNK/
2010
Ongoing: YES
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142063
Page 212 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-11-2020 20:30:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hao Hu
(pfe huh17)Query 1: Closed Response satisfies
query
Oct-06-2020 10:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-06-2020 10:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Diabetic NeuropathyChanged
Information
Oct-05-2020 21:43:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hao Hu
(pfe huh17)Query 1: Opened ClinQuery:
Neuropathy: Please
add the underlying
cause (e.g. diabetes,
hypertension etc.)
to the reported
term; if no
underlying cause
has been identified
please add
"idiopathic".
Oct-02-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NeuropathyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-02-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142064
Page 213 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.h Ongoing:
Date Location User Value Reason
Oct-02-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-02-2020 14:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:Congestive Hear
t Failure
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142065
Page 214 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.i Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Congestive Heart FailureInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-02-2020 14:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-02-2020 14:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-02-2020 14:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histo
ry Term:Generalized anxie
ty disorder
Start Date: UNK/UNK/2005
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142066
Page 215 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.j Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Generalized anxiety disorderInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-02-2020 14:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2005Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-02-2020 14:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Oct-02-2020 14:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:Depression
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142067
Page 216 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.k Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
DepressionInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-02-2020 14:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2000Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-02-2020 14:56:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Oct-02-2020 14:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:12
Medical History T
erm:Insomnia
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142068
Page 217 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.l Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
InsomniaInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-02-2020 14:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-02-2020 14:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Oct-02-2020 14:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:Excessive urin
ation
Start Date: UNK/UNK/19
55
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142069
Page 218 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.m Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Excessive urinationInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-02-2020 14:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1955Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-02-2020 14:57:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Oct-02-2020 14:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:14
Medical History T
erm:HIV
Start Date: UNK/UNK/1
991
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142070
Page 219 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.n Line/MH Number:
Date Location User Value Reason
Oct-02-2020 14:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 14:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HIVInitial Entry
1.n Start Date:
Date Location User Value Reason
Oct-02-2020 14:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/1991Initial Entry
1.n Ongoing:
Date Location User Value Reason
Oct-02-2020 14:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Feb-02-2021 09:52:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:15
Medical History T
erm:COPD
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142071
Page 220 of 435
***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, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.o Line/MH Number:
Date Location User Value Reason
Feb-02-2021 09:52:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-02-2021 09:52:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
COPDInitial Entry
1.o Start Date:
Date Location User Value Reason
Feb-02-2021 09:52:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
UNK/UNK/2009Initial Entry
1.o Ongoing:
Date Location User Value Reason
Feb-02-2021 09:52:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142072
Page 221 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-10-2020 02:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Avinash
Gawas
(pfe.gawasa)Query 2: Closed Closed per SITE
response, added to
PD tracker for
Clinical Review
Nov-09-2020 13:30:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 2: Answered E-diary was no
assigned in error.
Protocol deviation
has been recorded.
Nov-09-2020 06:47:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Swapna
Varikuti
(pfe.variks)Query 2: Opened PDQ : Response to
What is the subject
HIV status? is "The
subject is known to
be HIV
POSITIVE",
however eDairy
data is missing for
this subject for
Vaccination 1.
Please review and
update if the diary
data is available
else provide a
clarification.
Oct-06-2020 11:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Patricia
Banchero
(pfe.banchp)Query 1: Closed Response satisfies
query
Oct-06-2020 10:27:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered No significant
change in
antiretroviral
therapy during the 6
months prior to
enrollment
Oct-05-2020 15:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Patricia
Banchero
(pfe.banchp)Query 1: Opened GPDCLIN: Please
confirm if there has
been any significant
change in
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142073
Page 222 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
antiretroviral
therapy during the 6
months prior to
enrollment.
Oct-02-2020 14:58:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
The subject is known to be HIV
POSITIVEInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142074
Page 223 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Oct-08-2020 05:47:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Oct-07-2020 09:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-07-2020 09:27:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
QUEST CHANTILLY, QUEST
DIAGNOSTIC NICHOLS INS
TITUTE,CLIA 49D0221801,1
4225 Newbrook Drive,Chantill
y VA 20151Transcription Error
Oct-07-2020 02:57:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Swaranjali
Subhash Pawar
(pfe.pawars01)Query 1: Opened DM: A carriage 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).
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
QUEST CHANTILLY, QUEST
DIAGNOSTIC NICHOLS INS
TITUTE
CLIA 49D0221801
14225 Newbrook Drive
Chantilly VA 20151Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142075
Page 224 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
3. Collection Date:
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/17/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:2124
Test:: HIV RNA (Ultr
asensitive)
Result:: <20
Lab Normal Ra
nge:Low
20
High
10000000
Unit
/mLInitial Entry
5.a Sponsor ID:
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2124Initial Entry
5.a Test:
Date Location User Value Reason
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142076
Page 225 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB CHEMISTRY - 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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HIV RNA (Ultrasensitive)Initial Entry
5.a Result:
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
<20Initial Entry
5.a LNMT
Date Location User Value Reason
Oct-02-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Low
20
High
10000000
Unit
/mLInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142077
Page 226 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Oct-08-2020 05:45:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Oct-07-2020 09:27:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-07-2020 09:27:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
SUNQUEST, BOSTON MEDI
CAL CENTER LABORATOR
Y, CLIA 22D0867404, One Bo
ston Medical Center Place,Bost
on MA 02118Transcription Error
Oct-07-2020 02:57:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Swaranjali
Subhash Pawar
(pfe.pawars01)Query 1: Opened DM: A carriage 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).
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
SUNQUEST
BOSTON MEDICAL CENTE
R LABORATORY
CLIA 22D0867404
One Boston Medical Center Pla
ceInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142078
Page 227 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Boston MA 02118
3. Collection Date:
Date Location User Value Reason
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/17/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Nov-17-2020 14:51:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: 0.666
Lab Normal Range
:Low
.430
High
1.185
Unit
10^3/m
m3Changed
Information
Nov-17-2020 12:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: 0.666Ohh so it just
needed the 0. in
front of it, thats
why the .666 I put
got queried before.
Thank you so so so
so much for your
help!!!
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142079
Page 228 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Normal Range
:Low
430
High
1185
Unit
10^3/m
m3
Nov-16-2020 09:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: 666 10^3/
mm3
Lab Normal Rang
e:Low
430
High
1185
Unit
10^3/mm
3I am confused and
do not understand
what you are asking
for in these queries.
Would you be able
to rephrase it? Or
potentially give an
example so I can
better answer?
Thank you!
Nov-15-2020 10:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: .666
Lab Normal Range
:Low
430
High
1185
Unit
10^3/m
m3Changed
Information
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142080
Page 229 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-13-2020 15:21:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: 666/mm3
Lab Normal Range
:Low
430
High
1185
Unit
10^3/m
m3New Information
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:4722
Test:: CD4_PX4
722
Result:: 666
Lab Normal Range
:Low
430
High
1185
Unit
10^3/m
m3Initial Entry
5.a Sponsor ID:
Date Location User Value Reason
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4722Initial Entry
5.a Test:
Date Location User Value Reason
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142081
Page 230 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
CD4_PX4722Initial Entry
5.a Result:
Date Location User Value Reason
Nov-17-2020 15:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
Bouguermouh
(pfe.bougus)Query 1: Closed Response satisfies
query
Nov-17-2020 14:51:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Changed data per
query
Nov-17-2020 13:44:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
Bouguermouh
(pfe.bougus)Query 1: Reissued:Opened Clin: Please enter
for the normal range
LNMT Low (0.430)
and LNMT High
(1.185)
Nov-17-2020 12:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Ohh so it just
needed the 0. in
front of it, thats why
the .666 I put got
queried before.
Thank you so so so
so much for your
help!!!
Nov-17-2020 12:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
0.666Ohh so it just
needed the 0. in
front of it, thats why
the .666 I put got
queried before.
Thank you so so so
so much for your
help!!!
Nov-16-2020 16:54:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed
Hassan
(pfe.hassaa38)Query 1: Reissued:Opened My calculations are:
Result = 0.666 (No
units), Lab normal
range: 0.430, High:
1.185, Unit
10^3/mm3. If you
agree, please update
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142082
Page 231 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
this CRF as
indicated. Thanks
Nov-16-2020 09:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered I am confused and
do not understand
what you are asking
for in these queries.
Would you be able
to rephrase it? Or
potentially give an
example so I can
better answer?
Thank you!
Nov-16-2020 09:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
666 10^3/mm3I am confused and
do not understand
what you are asking
for in these queries.
Would you be able
to rephrase it? Or
potentially give an
example so I can
better answer?
Thank you!
Nov-15-2020 15:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
Bouguermouh
(pfe.bougus)Query 1: Reissued:Opened Clin: Please enter
the LNMT Low
(0.430) and LNMT
High (1.185), after
dividing the
numbers provided
(LNMT Low and
LNMT High) by
1000 to allow using
the Unit provided
“10^3/mm3”
equivalent to
“x1000/mm3”
Nov-15-2020 10:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Nov-15-2020 10:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
.666Changed
Information
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142083
Page 232 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-14-2020 19:48:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
Bouguermouh
(pfe.bougus)Query 1: Reissued:Opened Clin: Please enter
the CD4
ABSOLUTE
VALUE only,
LNMT Low and
LNMT High, after
dividing the
numbers provided
(CD4, LNMT Low
and LNMT High)
by 1000 to allow
using the Unit
provided
“10^3/mm3”
equivalent to
“x1000/mm3”
Nov-13-2020 15:21:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-13-2020 15:21:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
666/mm3New Information
Nov-12-2020 21:34:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
Bouguermouh
(pfe.bougus)Query 1: Opened Clin: Please enter
the CD4 absolute
values only, LNMT
Low and LNMT
High, after dividing
the number by 1000
to allow using the
Unit provided
“10^3/mm3”
equivalent to
“1000/mm3”
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
666Initial Entry
5.a LNMT
Date Location User Value Reason
Nov-17-2020 14:51:25
(UTC-05:00) EasternACV0PFEINFP6000  Taylor
StannardData Entry:
LowChanged
Information
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142084
Page 233 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LABORATORY DATA - HEMATOLOGY - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.tstannard) .430
High
1.185
Unit
10^3/mm3
Oct-02-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Low
430
High
1185
Unit
10^3/mm3Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142085
Page 234 of 435
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
208.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-02-2020 15:01:24
(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
Oct-02-2020 15:01:24
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34.6Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142086
Page 235 of 435
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier
::1
Temperature: 97.8
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-02-2020 15:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142087
Page 236 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-02-2020 15:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Oct/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-02-2020 15:02:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
266982Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142088
Page 237 of 435
***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: 10151238 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-05-2020 11:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 11:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 11:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 11:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-05-2020 11:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020 11:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0KVInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142089
Page 238 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-05-2020 11:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0KVInitial Entry
5.b
Date Location User Value Reason
Oct-05-2020 11:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0KPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-05-2020 11:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0KPInitial Entry
5.c
Date Location User Value Reason
Oct-05-2020 11:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0KRTranscription Error
(DELETED)
Oct-05-2020 11:07:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0KRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-05-2020 11:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0KRTranscription Error
(DELETED)
Oct-05-2020 11:07:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0KRInitial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142090
Page 239 of 435
***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: 10151238 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d
Date Location User Value Reason
Oct-05-2020 11:11:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9HK0Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-05-2020 11:11:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HK0Initial Entry
090177e196ae3fe8\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0142091
Page 240 of 435
***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: 10151238 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-05-2020 11:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-05-2020 11:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020 11:15:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-05-2020 11:15:49
(UTC-05
…[truncated]