125742 S1 M5 CRF c4591001 1015 10151035

Document text

Page 1 of 154
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140697
Page 2 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/16/2020
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140698
Page 3 of 154
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10151035]
2.Birth Date: /1995
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0140699
Page 4 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/16/2020
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140700
Page 5 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140701
Page 6 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140702
Page 7 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140703
Page 8 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/16/2020
2.Weight: [138.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [23.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140704
Page 9 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140705
Page 10 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/16/2020
2.Randomization Number: [51423]
3.Randomization Group: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140706
Page 11 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
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 [BLD02H]
5.bSample ID [BLD02J]
5.cSample ID [BM8FBH]
5.dSample ID [BM8FBF]
5.eSample ID [BM8FBG]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140707
Page 12 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/16/2020
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 [BM8FBB]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140708
Page 13 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/16/2020 12:50
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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140709
Page 14 of 154
***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: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140710
Page 15 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140711
Page 16 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140712
Page 17 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140713
Page 18 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140714
Page 19 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140715
Page 20 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP9HXV]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140716
Page 21 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 15:54
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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140717
Page 22 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140718
Page 23 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140719
Page 24 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140720
Page 25 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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 [BLD0L1]
5.bSample ID [BP9HK8]
5.cSample ID [BLD0L3]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140721
Page 26 of 154
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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/1/2021
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140722
Page 27 of 154
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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/1/2021
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 [BSH1J1]
5.bSample ID [BSH1J2]
5.cSample ID [BSH1J3]
5.dSample ID [BR70G3]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140723
Page 28 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140724
Page 29 of 154
***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: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140725
Page 30 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140726
Page 31 of 154
***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: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140727
Page 32 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140728
Page 33 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140729
Page 34 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140730
Page 35 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140731
Page 36 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140732
Page 37 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140733
Page 38 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140734
Page 39 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140735
Page 40 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/6/2020
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140736
Page 41 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140737
Page 42 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/6/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Patient called reporting symptoms reported in eDiary, wanted to know if she
may take pain medication. Advised to take pain medication. Agreed to contact
with any other issues or concerns.]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140738
Page 43 of 154
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140739
Page 44 of 154
***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: 10151035 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: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140740
Page 45 of 154
***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: 10151035 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:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140741
Page 46 of 154
***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: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140742
Page 47 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Swollen lymph node - left ar
mpit axillary Sep/4/2020
17:00 NO
End Date Time:
Sep/8/2020 UNK:UNK
 Repeating
Pages
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140743
Page 48 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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)[Swollen lymph node - left armpit axillary]
4.Start Date Time: Sep/4/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140744
Page 49 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140745
Page 50 of 154
***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: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140746
Page 51 of 154
***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: 10151035 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[ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140747
Page 52 of 154
***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: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140748
Page 53 of 154
***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: 10151035 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: //
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140749
Page 54 of 154
***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: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140750
Page 55 of 154
***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: 10151035 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?
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140751
Page 56 of 154
***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: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140752
Page 57 of 154
***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: 10151035 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?
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140753
Page 58 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140754
Page 59 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140755
Page 60 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140756
Page 61 of 154
***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: 10151035 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:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140757
Page 62 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140758
Page 63 of 154
***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: 10151035 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?
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140759
Page 64 of 154
***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: 10151035 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: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140760
Page 65 of 154
***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: 10151035 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: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140761
Page 66 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140762
Page 67 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140763
Page 68 of 154
***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: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140764
Page 69 of 154
***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: 10151035 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 [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140765
Page 70 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140766
Page 71 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140767
Page 72 of 154
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140768
Page 73 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140769
Page 74 of 154
***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: 10151035 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: [ ]
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140770
Page 75 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140771
Page 76 of 154
***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: 10151035 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
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140772
Page 77 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Elizabeth
Barnett Approved Mar-11-2021 10:21:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140773
Page 78 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-17-2020 12:41:47 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140774
Page 79 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-17-2020 12:42:12 (UTC-05:00) Eastern
Time (US & Canada)Taylor Stannard
(pfe.tstannard)Not Applicable
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140775
Page 80 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Elizabeth
Barnett Approved Mar-11-2021 10:21:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Taylor Stannard  N/A Mar-03-2021 11:50:27 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Jan-21-2021 19:46:55 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ElizabethBarnett, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Taylor Stannard  N/A Dec-23-2020 13:15:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140776
Page 81 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Elizabeth
Barnett Approved Oct-26-2020 13:37:45 (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 Oct-22-2020 14:52:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Elizabeth
Barnett Approved Oct-22-2020 06:10:45 (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.
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140777
Page 82 of 154
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020 12:41:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020 12:41:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140778
Page 83 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 12:41:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/16/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140779
Page 84 of 154
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 12:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10151035Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 12:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1995Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 12:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 12:41:31
(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
Aug-17-2020 12:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
WHITEInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
(b) (6)
FDA-CBER-2021-5683-0140780
Page 85 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 12:41:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/16/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140781
Page 86 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-17-2020 12:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020 12:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020 12:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140782
Page 87 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
138.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.0Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140783
Page 88 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020 12:42:40
(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
Aug-17-2020 12:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140784
Page 89 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140785
Page 90 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-17-2020 12:42:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140786
Page 91 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020 12:43:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020 12:43:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
51423Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140787
Page 92 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 16:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 16:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 04:58:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 3: Closed Response satisfies
query
Sep-06-2020 19:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Sep-06-2020 19:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/16/2020Transcription Error
Sep-05-2020 22:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R
(pfe.rb01)Query 3: Opened Sample collected on
17AUG2020 which
is after Vaccination
date of 16Aug2020.
Please Verify the
dates and update as
appropriate. Else
specify in the item
"If no sample was
collected or sample
was not collected
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140788
Page 93 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
according to
protocol, please
provide".
Sep-02-2020 08:32:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 2: Closed Response satisfies
query
Sep-01-2020 10:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 2: Answered Changed data per
query
Sep-01-2020 08:28:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 2: Opened DM: Barcode
BM8FHB was
received by the lab
but missing in
inform. Please
review and update
appropriately or
submit a SCF.
Aug-17-2020 16:30:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 16:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 16:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 16:30:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD02HInitial Entry
5.a Sample ID
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140789
Page 94 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User ValueReason
Aug-18-2020
01:33:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Aug-17-2020
20:17:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query
1: An
swere
dOriginal value is
correct
Aug-17-2020
19:41:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW4228507;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Aug-17-2020
16:30:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data
Entry
:
BLD0
2HInitial Entry
5.b
Date Location User Value Reason
Aug-17-2020 20:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD02JTranscription Error
Aug-17-2020 16:30:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD02HInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140790
Page 95 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Sample ID
Date Location User ValueReason
Aug-18-2020
01:33:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_01
Aug-17-2020
20:17:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Aug-17-2020
20:17:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data
Entry
:
BLD0
2JTranscription Error
Aug-17-2020
19:41:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW4228508;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Aug-17-2020
16:30:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data
Entry
:
BLD0
2HInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 13:37:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FBHTranscription Error
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140791
Page 96 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020 10:25:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FHBTranscription Error
Aug-28-2020 12:46:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FBHTranscription Error
Aug-17-2020 20:16:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FHBInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140792
Page 97 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 08:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 3: Closed error
Oct-21-2020 06:03:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ankita Thakur
(pfe.thakua20)Query 3: Reissued:Opened DM: Thank you for
the response, at
Visit 1 , now the
form is unfrozen,
hence please update
the data appropriate
as per the below
query. Else clarify.
Oct-20-2020 10:23:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 3: Answered Please unfreeze so I
may update, thanks!
Oct-20-2020 08:15:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kiran Potdar
(pfe.potdak02)Query 3: Opened LIMS Query: As
per lab, sample ID
is BM8FHB and not
BM8FBH as
reported here.
Please check and
correct the data,
else clarify.
Sep-04-2020 04:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 2: Closed Response satisfies
query
Sep-03-2020 13:37:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Sep-03-2020 13:37:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FBHTranscription Error
Sep-03-2020 11:52:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 2: Opened DM: Lab received
BM8FBH. Please
confirm barcode
and update
accordingly or
submit SCF.
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140793
Page 98 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020 10:25:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FHBTranscription Error
Aug-28-2020 13:52:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 1: Closed Response satisfies
query
Aug-28-2020 12:46:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Aug-28-2020 12:46:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FBHTranscription Error
Aug-28-2020 10:55:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 1: Opened DM: BM8FHB
entered instead of
BM8FBH. Please
confirm barcode
and update
accordingly or
clarify.
Aug-17-2020 20:16:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FHBInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 16:06:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FBFTranscription Error
Aug-28-2020 16:06:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FF5Transcription Error
Aug-18-2020 10:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FBFInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140794
Page 99 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 16:06:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FBFTranscription Error
Aug-28-2020 16:06:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FF5Transcription Error
Aug-18-2020 10:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FBFInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020 10:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FBGInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-18-2020 10:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FBGInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140795
Page 100 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 13:15:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 13:15:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 13:15:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 13:15:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 13:15:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Aug/16/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 13:15:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BM8FBBInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140796
Page 101 of 154
***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: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 13:15:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BM8FBBInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140797
Page 102 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Aug/16/2020 12:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) EasternACV0PFEINFP6000  Taylor
StannardData Entry:
LEFTInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140798
Page 103 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.tstannard)
7. Route:
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-17-2020 12:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140799
Page 104 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-17-2020 12:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140800
Page 105 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 05:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Sep-06-2020 19:34:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Query 1: Answered Changed data per
query
Sep-05-2020 22:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R
(pfe.rb01)Query 1: Opened Please complete
"Electronic sample
tracking-NASAL
SWAB" CRF.
Sep-04-2020 15:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140801
Page 106 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140802
Page 107 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140803
Page 108 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.c Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.e
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140804
Page 109 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140805
Page 110 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140806
Page 111 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140807
Page 112 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140808
Page 113 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 15:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140809
Page 114 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 15:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 15:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 15:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020 15:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020 15:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140810
Page 115 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 15:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140811
Page 116 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140812
Page 117 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 15:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140813
Page 118 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-06-2020 19:34:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-06-2020 19:34:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-06-2020 19:34:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-06-2020 19:34:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-06-2020 19:34:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-06-2020 19:34:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9HXVInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140814
Page 119 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Sep-06-2020 19:34:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HXVInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140815
Page 120 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020
08:40:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Swapna Varikuti
(pfe.variks)Query
1: Clos
edResponse satisfies
query
Sep-09-2020
11:30:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query
1: Ans
weredChanged data per
query
Sep-07-2020
03:25:30
(UTC-05:00)
Eastern TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Ope
nedPDQ: Subject has
reported with
Severe
symptoms/reactions
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140816
Page 121 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US &
Canada)on '2020-09-05'.
Per protocol,
subjects
experiencing Grade
3 local reactions
should be
contacted. Please
confirm if an
UNPLANNED
CONTACT was
made and update
the corresponding
form as
appropriate.
"[malipn01
SDQ=4039]"
Sep-04-2020
15:54:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data
Entry:
Sep/4/
2020 1
5:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140817
Page 122 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 15:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YESInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140818
Page 123 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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-23-2020 03:53:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Minal Pathak
(pfe.patham13)Query 2: Closed Response satisfies
query
Oct-22-2020 14:55:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 2: Answered Changed data per
query
Oct-22-2020 10:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 2: Opened DM1: Thank you for
response. Please
review if data is
available and
provide details on
‘Immunogenicity
form' at this visit.
Oct-21-2020 01:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe mahadp07)Query 1: Closed Closed as query kept
in candidate state.
Oct-21-2020 01:00:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe mahadp07)Query 2: Candidate DM1: Thank you for
response. Please
review if data is
available and
provide details on
‘Immunogenicity
form' at this visit.
Oct-16-2020 01:02:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pratiksha
Mahadik
(pfe mahadp07)Query 1: Reissued:Opened DM1: Thank you for
response. Please
keep this query open
at your end. Once
data is available and
updated, respond to
the query.
Oct-15-2020 14:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Query 1: Answered Hello, we are
currently trying to
find the barcodes for
this participant. Will
update as soon as the
lab staff can get it to
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140819
Page 124 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
us.
Oct-09-2020 10:11:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM: Kindly review
and complete
‘Immunogenicity
form' at this visit.
Thank you.
Oct-02-2020 15:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data Entry:
Oct/2/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140820
Page 125 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140821
Page 126 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140822
Page 127 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.c Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.e
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140823
Page 128 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140824
Page 129 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140825
Page 130 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
LEFTInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140826
Page 131 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140827
Page 132 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 15:37:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140828
Page 133 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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-22-2020 14:52:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 14:52:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 14:52:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 14:52:35
(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-22-2020 14:52:35
(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-22-2020 14:52:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0L1Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140829
Page 134 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 14:52:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0L1Initial Entry
5.b
Date Location User Value Reason
Oct-22-2020 14:54:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BP9HK8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 14:54:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BP9HK8Initial Entry
5.c
Date Location User Value Reason
Oct-22-2020 14:54:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BLD0L3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 14:54:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BLD0L3Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140830
Page 135 of 154
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 11:50:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Mar/1/2021Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140831
Page 136 of 154
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 11:50:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 11:50:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 11:50:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 11:50:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-03-2021 11:50:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-03-2021 11:50:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH1J1Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140832
Page 137 of 154
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Mar-03-2021 11:50:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1J1Initial Entry
5.b
Date Location User Value Reason
Mar-03-2021 11:51:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH1J2Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021 11:51:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1J2Initial Entry
5.c
Date Location User Value Reason
Mar-03-2021 11:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BSH1J3Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-03-2021 11:52:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BSH1J3Initial Entry
5.d
Date Location User Value Reason
Mar-03-2021 11:53:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sample ID: BR70G3Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140833
Page 138 of 154
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.d Sample ID
Date Location User Value Reason
Mar-03-2021 11:53:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
BR70G3Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140834
Page 139 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020 11:29:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/6/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140835
Page 140 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Assessments
Date Location User Value Reason
Sep-09-2020 11:30:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-09-2020 11:29:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form
is not entered.
Please review and
update as
appropriate.
Sep-09-2020 11:29:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140836
Page 141 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-09-2020 11:30:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-09-2020 11:30:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
YES
Date of Contact:
Sep/6/2020
Contact Outcome:
VISIT NOT REQUIRED, IN
VESTIGATOR DECISIONInitial Entry
3. Comments:
Date Location User Value Reason
Sep-12-2020
05:51:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Premraj Bhoyar
(pfe.bhoyap)Query 1:
ClosedData updated
by site.
Sep-11-2020
13:14:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredNew
Information
Sep-11-2020
13:14:29
(UTC-05:00)ACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data Entr
y:
Patient calNew
Information
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140837
Page 142 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Eastern Time
(US &
Canada)led reporti
ng sympto
ms reporte
d in eDiar
y, wanted
to know if
she may ta
ke pain m
edication.
Advised t
o take pai
n medicati
on. Agree
d to conta
ct with an
y other iss
ues or con
cerns.
Sep-10-2020
17:35:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1:
OpenedThe following
text was
indicated in
the comment
field
[fever,muscle
soreness]. For
any
symptoms,
AEs, or other
key data
should be
collected on
the
appropriate
page or
eDiary. Please
review and
update as
necessary.
"[nazairl
SDQ=5843]"
Sep-09-2020
11:30:34
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Taylor Stannard
(pfe.tstannard)Data Entr
y:
Patient cal
led reportiInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140838
Page 143 of 154
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/06/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(US &
Canada)ng low-gr
ade fever
and muscl
e soreness,
wanted to
know if sh
e may take
pain medi
cation. Ad
vised to ta
ke pain m
edication.
Agreed to
contact wi
th any oth
er issues o
r concerns
.
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140839
Page 144 of 154
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 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-05-2020 10:58:53
(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-05-2020 10:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-05-2020 10:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140840
Page 145 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Taylor
Stannard
(pfe.tstannard)Form Created
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140841
Page 146 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-21-2020 20:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Xiaoxia Liu
(pfe.xiaoxl)Query 1: Closed Response satisfies
query
Oct-20-2020 10:37:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-20-2020 10:37:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Swollen lymph node - left armpi
t axillaryNew Information
Oct-20-2020 01:16:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sathenapalli
Suguna
Srujan
(pfe.srujas)Query 1: Opened ClinQuery: Swollen
lymph node –
armpit: please
specify location re
axillary and
whether bilateral,
left, or right
Oct-19-2020 21:36:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Xiaoxia Liu
(pfe.xiaoxl)Query 1: Candidate ClinQuery: Swollen
lymph node –
armpit: please
specify location re
axillary and
whether bilateral,
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140842
Page 147 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
left, or right
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Swollen lymph node - armpitInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-05-2020 10:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Patricia
Banchero
(pfe.banchp)Query 1: Closed Response satisfies
query
Oct-05-2020 10:31:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-05-2020 10:31:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/4/2020 17:00Transcription Error
Oct-05-2020 10:25:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Patricia
Banchero
(pfe.banchp)Query 1: Opened GPDCLIN: The
event is deemed
related to study
treatment but start
time is prior to
vaccination. Please
review and update
as applicable.
Otherwise, please
clarify.
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Sep/4/2020 15:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NO
End Date Time:
Sep/8/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140843
Page 148 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140844
Page 149 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-02-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
NOInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140845
Page 150 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-23-2020 13:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140846
Page 151 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-23-2020 13:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140847
Page 152 of 154
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-23-2020 13:15:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-23-2020 13:15:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Taylor
Stannard
(pfe.tstannard)Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140848
Page 153 of 154
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-05-2020 10:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-17-2020 12:43:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-17-2020 12:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-05-2020 10:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
Aug-17-2020 12:43:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/16/2020Initial Entry
Aug-17-2020 12:42:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/16/2020Initial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140849
Page 154 of 154
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1015 Site Name: (1015) Boston Medical Center
Subject No: 10151035 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 06:10:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Elizabeth
Barnett
(pfe.ebarnett)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fea\Final\Final On: 01-Apr-2021 05:25 (GMT)
FDA-CBER-2021-5683-0140850