125742 S1 M5 CRF c4591001 1260 12601035

Document text

Page 1 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835893
Page 2 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/31/2020
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835894
Page 3 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12601035]
2.Birth Date: 1951
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835895
Page 4 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835896
Page 5 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835897
Page 6 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835898
Page 7 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[menopause]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835899
Page 8 of 231
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [241.8]
3.Unit: LB
4.Height: [65.7]
5.Unit: in
6.Body Mass Index: [39.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835900
Page 9 of 231
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835901
Page 10 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [247301]
3.Randomization Group: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835902
Page 11 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BPT77X]
5.bSample ID [BPT77Y]
5.cSample ID [BPT77Z]
5.dSample ID [BNV65N]
5.eSample ID [BNV65P]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835903
Page 12 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BPT77S]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835904
Page 13 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/31/2020 15:04
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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835905
Page 14 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835906
Page 15 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835907
Page 16 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835908
Page 17 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835909
Page 18 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BP26NM]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835910
Page 19 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/21/2020 15:48
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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835911
Page 20 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835912
Page 21 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BP26W9]
5.bSample ID [BNTX52]
5.cSample ID [BNTX53]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835913
Page 22 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835914
Page 23 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835915
Page 24 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835916
Page 25 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835917
Page 26 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835918
Page 27 of 231
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835919
Page 28 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835920
Page 29 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835921
Page 30 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835922
Page 31 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835923
Page 32 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835924
Page 33 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835925
Page 34 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835926
Page 35 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835927
Page 36 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  headache  Sep/1/2020 07:3
0 NO
End Date Time:
Sep/28/2020 09:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  traumatic subdural hemorrh
age Jan/31/2021 15:
45 NO
End Date Time:
Feb/2/2021 17:00
 Repeating
Pages
 3.ADVERSE EVE
NT 3  lip laceration  Jan/31/2021 15:
45 NO
End Date Time:
Feb/2/2021 UNK:UNK
 Repeating
Pages
 4.ADVERSE EVE
NT 4  chipped teeth  Jan/31/2021 15:
45 NO
End Date Time:
Feb/4/2021 09:00
 Repeating
Pages
 5.ADVERSE EVE
NT 5  calcified meningioma  Jan/31/2021 15:
45 NO
End Date Time:
Feb/2/2021 UNK:UNK
 Repeating
Pages
 6.ADVERSE EVE
NT 6  arachnoid cyst  Jan/31/2021 15:
45 NO
End Date Time:
Feb/2/2021 UNK:UNK
 Repeating
Pages
 7.ADVERSE EVE
NT 7  fall from walking dog  Jan/31/2021 15:
45 NO
End Date Time:
Feb/2/2021 UNK:UNK
 Repeating
Pages
 8.ADVERSE EVE
NT 8  soreness at the injection sit
e Jan/13/2021 18:
00 NO
End Date Time:
Jan/14/2021 08:00
 Repeating
Pages
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835928
Page 37 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[headache]
4.Start Date Time: Sep/1/2020 07:30
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES Comments
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[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835929
Page 38 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[traumatic subdural hemorrhage]
4.Start Date Time: Jan/31/2021 15:45
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/2/2021 17:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall from walking dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835930
Page 39 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[2021113437]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835931
Page 40 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[lip laceration]
4.Start Date Time: Jan/31/2021 15:45
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/2/2021 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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall from walking dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835932
Page 41 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835933
Page 42 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chipped teeth]
4.Start Date Time: Jan/31/2021 15:45
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/4/2021 09:00
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall from walking dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835934
Page 43 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835935
Page 44 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[calcified meningioma]
4.Start Date Time: Jan/31/2021 15:45
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/2/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[incidental finding not requiring surgery after fall from walking dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835936
Page 45 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835937
Page 46 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[arachnoid cyst]
4.Start Date Time: Jan/31/2021 15:45
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/2/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[incidental finding not requiring surgery after fall from walking dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835938
Page 47 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835939
Page 48 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall from walking dog]
4.Start Date Time: Jan/31/2021 15:45
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/2/2021 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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall from walking dog]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835940
Page 49 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835941
Page 50 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[soreness at the injection site]
4.Start Date Time: Jan/13/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/14/2021 08:00
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
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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835942
Page 51 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835943
Page 52 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835944
Page 53 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835945
Page 54 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medicat
ionStart Dat
eForm Instance
 1.1  VACCINATIONS  NO  Influenza Vaccina
tion Oct/14/20
20 Repeating
Pages
 2.2  VACCINATIONS  NO  Tetanus vaccine  Feb/2/202
1 Repeating
Pages
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835946
Page 55 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications Pre-specified: NO
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).[Influenza Vaccination]
5.Date: Oct/14/2020
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835947
Page 56 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications Pre-specified: NO
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).[Tetanus vaccine]
5.Date: Feb/2/2021
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835948
Page 57 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835949
Page 58 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835950
Page 59 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835951
Page 60 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835952
Page 61 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835953
Page 62 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835954
Page 63 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835955
Page 64 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835956
Page 65 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835957
Page 66 of 231
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835958
Page 67 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835959
Page 68 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835960
Page 69 of 231
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835961
Page 70 of 231
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835962
Page 71 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835963
Page 72 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/13/2021
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835964
Page 73 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835965
Page 74 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835966
Page 75 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835967
Page 76 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BPVNVM]
5.bSample ID [BNTXDB]
5.cSample ID [BNTXDC]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835968
Page 77 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BPVNVM ]
5.bSample ID [BPVNVK]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835969
Page 78 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 15:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835970
Page 79 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835971
Page 80 of 231
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835972
Page 81 of 231
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835973
Page 82 of 231
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835974
Page 83 of 231
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835975
Page 84 of 231
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/4/2021
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 [BPVNY1]
5.bSample ID [BPVNZJ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835976
Page 85 of 231
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Feb/4/2021
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/4/2021 10:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835977
Page 86 of 231
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835978
Page 87 of 231
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835979
Page 88 of 231
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835980
Page 89 of 231
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835981
Page 90 of 231
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835982
Page 91 of 231
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835983
Page 92 of 231
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835984
Page 93 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835985
Page 94 of 231
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835986
Page 95 of 231
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835987
Page 96 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-31-2020 21:03:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835988
Page 97 of 231
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Aug-31-2020 21:06:11 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835989
Page 98 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-21-2020 20:53:15 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835990
Page 99 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Sep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835991
Page 100 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Sep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835992
Page 101 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Sep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835993
Page 102 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Sep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835994
Page 103 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Sep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835995
Page 104 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aSep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835996
Page 105 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aSep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835997
Page 106 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aSep-21-2020 20:53:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835998
Page 107 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Sep-21-2020 16:32:43 (UTC-05:00) Eastern Time (US
& Canada)Tylenol 325mg po daily (currently using)
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835999
Page 108 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-13-2021 15:58:05 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836000
Page 109 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836001
Page 110 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836002
Page 111 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836003
Page 112 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836004
Page 113 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836005
Page 114 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836006
Page 115 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aJan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836007
Page 116 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aJan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836008
Page 117 of 231
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aJan-13-2021 15:58:41 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836009
Page 118 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-04-2021 16:28:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836010
Page 119 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836011
Page 120 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836012
Page 121 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836013
Page 122 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836014
Page 123 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Feb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836015
Page 124 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aFeb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836016
Page 125 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aFeb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836017
Page 126 of 231
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6.aFeb-04-2021 16:28:31 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836018
Page 127 of 231
***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, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-03-2021 16:19:42 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Jan-25-2021 18:44:01 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFinberg, 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.
 N/A Jan-12-2021 15:39:12 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-02-2020 15:42:49 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836019
Page 128 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 21:02:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 21:02:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836020
Page 129 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-31-2020 21:02:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836021
Page 130 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 21:02:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12601035Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 21:02:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 21:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 21:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 21:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836022
Page 131 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 21:03:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836023
Page 132 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-31-2020 21:03:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 21:03:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-31-2020 21:03:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836024
Page 133 of 231
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Aug-31-2020 21:08:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:menopause
Start Date: UNK/UNK/200
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-31-2020 21:08:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 21:08:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
menopauseInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-31-2020 21:08:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-31-2020 21:08:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836025
Page 134 of 231
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
241.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-31-2020 21:07:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened lb is selected for
weight unit, then in is
expected to be selected
for Height unit. Please
check and update data
as appropriate.
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-31-2020 21:07:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 21:07:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
65.7Transcription Error
Aug-31-2020 21:07:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Height 167 is outside
of Normal Range 140 -
198 for cm or 55 - 80
for in.
Aug-31-2020 21:07:12 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836026
Page 135 of 231
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-05:00) Eastern Time
(US & Canada)167.0
5. Unit:
Date Location User Value Reason
Aug-31-2020 21:07:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inTranscription Error
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-31-2020 21:07:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
39.4Transcription Error
Aug-31-2020 21:07:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6.1Transcription Error
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.5
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836027
Page 136 of 231
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 21:07:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836028
Page 137 of 231
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 21:06:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020 21:06:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 21:06:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 21:06:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-31-2020 21:06:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836029
Page 138 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-31-2020 21:07:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-31-2020 21:07:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
247301Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836030
Page 139 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 21:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 21:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 19:36:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 21:03:58
(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-31-2020 21:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 19:36:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT77XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 19:36:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPT77XInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836031
Page 140 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Sep-01-2020 19:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT77YInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-01-2020 19:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPT77YInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 19:37:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT77ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-01-2020 19:37:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPT77ZInitial Entry
5.d
Date Location User Value Reason
Sep-01-2020 19:37:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV65NInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-01-2020 19:37:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNV65NInitial Entry
5.e
Date Location User Value Reason
Sep-01-2020 19:37:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV65PInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836032
Page 141 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.e Sample ID
Date Location User Value Reason
Sep-01-2020 19:37:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNV65PInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836033
Page 142 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 21:04:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 21:04:11
(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-02-2020 13:32:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-02-2020 04:11:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-31-2020 21:04:11
(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-31-2020 21:04:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 13:32:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT77SInitial Entry
5.a Sample ID
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836034
Page 143 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-02-2020 13:32:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPT77SInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836035
Page 144 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 21:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 21:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 21:05:54
(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-31-2020 21:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/31/2020 15:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 21:05:54
(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-31-2020 21:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836036
Page 145 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-31-2020 21:05:54
(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-31-2020 21:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-31-2020 21:05:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836037
Page 146 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-31-2020 21:06:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836038
Page 147 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020 20:53:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836039
Page 148 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 20:54:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 20:54:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.4
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 20:54:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020 20:54:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 20:54:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 20:54:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836040
Page 149 of 231
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Identi
fier:Not Applica
ble
Test:: Not Applica
ble
Result:: Not Applica
bleInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836041
Page 150 of 231
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-21-2020 20:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836042
Page 151 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 20:53:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 20:53:25
(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-22-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 03:51:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-21-2020 20:53:25
(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-21-2020 20:53:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26NMInitial Entry
5.a Sample ID
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836043
Page 152 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-22-2020 10:04:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP26NMInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836044
Page 153 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-21-2020 20:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 20:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 20:53:45
(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-21-2020 20:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020 15:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 20:53:45
(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-21-2020 20:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836045
Page 154 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-21-2020 20:53:45
(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
Sep-21-2020 20:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-21-2020 20:53:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836046
Page 155 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020 16:03:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836047
Page 156 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 16:03:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 16:03:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 16:14:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-26-2020 16:03:21
(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-26-2020 16:03:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 16:14:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26W9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 16:14:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP26W9Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836048
Page 157 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Oct-26-2020 16:14:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX52Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 16:14:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX52Initial Entry
5.c
Date Location User Value Reason
Oct-26-2020 16:14:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX53Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 16:14:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX53Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836049
Page 158 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020 16:03:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 16:03:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 16:03:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836050
Page 159 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836051
Page 160 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836052
Page 161 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836053
Page 162 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836054
Page 163 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836055
Page 164 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836056
Page 165 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836057
Page 166 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836058
Page 167 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 07:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-08-2020 12:49:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-08-2020 11:58:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Oct-08-2020 11:58:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/28/2020 09:00New Information
Oct-07-2020 02:43:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY: Please
review if this event
'Headache' remains
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836059
Page 168 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
ongoing or if an update
to this field and
outcome status can be
entered.
Oct-06-2020 10:57:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Candidate CLINQUERY: Please
review if this event
'Headache' remains
ongoing or if an update
to this field and
outcome status can be
entered.
Sep-23-2020 11:36:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-22-2020 16:28:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered still ongoing
Sep-22-2020 13:53:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
review if this event
'Headache' remains
ongoing or if an update
to this field and
outcome status can be
entered.
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836060
Page 169 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-08-2020 11:58:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-08-2020 11:58:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-08-2020 11:58:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE headache:
Response to "What was
the outcome of this
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836061
Page 170 of 231
***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: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
adverse event?" is 'Not
Recovered/Not
Resolved' but AE End
Date/Time is present.
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-21-2020 16:31:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836062
Page 171 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021
05:52:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Closed SDB term updated
Mar-02-2021
10:01:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answered Changed data per
query
Feb-19-2021
11:50:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response satisfies
query
Feb-19-2021
05:36:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON:
AER#2021113437,the
term was reported as
'brain bleeding' in
Safety database while
updated to 'traumatic
subdural hemorrhage'
in AE CRF. Please
confirm correct term.If
safety update is
required, please submit
a follow-up form.
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836063
Page 172 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-17-2021
00:41:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has been
closed.
Feb-16-2021
22:18:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed Information
Feb-16-2021
22:18:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-16-2021
22:18:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
traumatic subdural
hemorrhageChanged Information
Feb-10-2021
08:17:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened CLINICAL_ If the
traumatic accident was
either a fall, then fall
needs to be reported
recorded as separate
AEs as well. Pls see
specific CRF
completion guidelines
(8.50.2.2./falls).
Thanks.
Feb-04-2021
03:56:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Multiple concepts in
the term BRAIN
BLEED S/P FALL
WHILE WALKING
DOG. Split the term
into
POST-TRAUMATIC
BRAIN BLEED and
S/P FALL WHILE
WALKING DOG and
submit separately.
Thank you.
Feb-03-2021
16:19:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
brain bleed s/p fall
while walking dogInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836064
Page 173 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4. Start Date Time:
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 15:45Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-04-2021 22:43:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/2/2021 17:00Transcription Error
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-25-2021 07:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 13:29:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-24-2021 13:29:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Transcription Error
Feb-22-2021 13:04:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened GPD CLINQUERY:
Please confirm that the
AE does not meet a
higher toxicity grade,
given that event was
serious.
Feb-03-2021 16:19:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836065
Page 174 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-05-2021 08:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 16:20:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-03-2021 16:20:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolo
ng hospitalization?
YES
Did this serious event result in persist
ent or significant disability/incapacity
?
NO
Is this serious event life threatening?
NO
Other medically important serious eve
nt
YESNew Information
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please review
and update as
appropriate.
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE brain bleed s/p
fall while walking dog:
Response to "Is the
adverse event serious?"
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836066
Page 175 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolo
ng hospitalization?
YES
Is this serious event life threatening?
NO
Other medically important serious eve
nt
YESInitial 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
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), th
is event is due to:
OTHER
If Other, specify:
fall from walking dogInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836067
Page 176 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-04-2021 16:16:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Mar-02-2021 10:17:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered updated report to safety
with new data on 3/1/21
Feb-19-2021 11:52:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Pls clarify, no updates
have been noted in the
safety report.
Feb-16-2021 22:20:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-16-2021 22:20:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESChanged Information
Feb-10-2021 08:24:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened MEDICAL
MONITOR_ (AER#
2021113437)
Information on workup
(including lab
results/imaging) and
management in the ICU
are not described. Pls
provide this
information in a FU
report. Thank you.
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-03-2021 16:20:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836068
Page 177 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User ValueReason
Mar-05-2021
12:04:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Mar-04-2021
22:46:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredChanged data per query
Mar-04-2021
03:11:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Mar-03-2021
18:11:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW7587895;Response to "What
was the outcome of this adverse
event?" is 'Recovered/Resolved' or
'Recovered/Resolved with Sequelae'
but End Date/Time is missing.
Please review and update as
appropriate.
Mar-03-2021
12:12:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredChanged Information
Mar-03-2021
12:12:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
RECO
VERE
D/RE
SOLV
EDChanged Information
Mar-03-2021
05:51:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2021113437,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
ERING/RESOLVING on AE CRF.
Please confirm correct outcome. If
safety update is required, please
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836069
Page 178 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
submit a follow-up form.
Feb-03-2021
16:19:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
RECO
VERI
NG/R
ESOL
VINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-03-2021 16:19:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-05-2021 08:57:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2021113437Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836070
Page 179 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
lip lacerationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 15:45Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/2/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836071
Page 180 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
Mar-11-2021 00:38:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-10-2021 20:44:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered updated SAE faxed to
safety this afternoon
Mar-09-2021 10:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON: Per
confirmation from PSSR,
no follow-up has been
received downgrading the
events to non serious.
Please submit a follow up
SAE form to indicate that
the events are no longer
serious.
Mar-08-2021 01:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-04-2021 22:41:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered SAFETY FORM
UPDATED TO NOT
SERIOUS, JUST AE
Mar-03-2021 09:33:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021113437
Lip laceration(onset
date:31Jan2021)was
reported as serious in
Safety database but
nonserious in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836072
Page 181 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), th
is event is due to:
OTHER
If Other, specify:
fall from walking dogInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836073
Page 182 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:25:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836074
Page 183 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
chipped teethInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 15:45Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/4/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836075
Page 184 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
Mar-11-2021 00:38:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-10-2021 20:44:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered updated form to safety
faxed this afternoon
Mar-09-2021 10:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON: Per
confirmation from PSSR,
no follow-up has been
received downgrading the
events to non serious.
Please submit a follow up
SAE form to indicate that
the events are no longer
serious.
Mar-08-2021 01:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-04-2021 22:46:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered safety form updated from
serious AE to just AE
Mar-03-2021 09:34:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021113437
Tooth fracture(onset
date:31Jan2021)was
reported as serious in
Safety database but
nonserious in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836076
Page 185 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), th
is event is due to:
OTHER
If Other, specify:
fall from walking dogInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836077
Page 186 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:27:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836078
Page 187 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
calcified meningiomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 15:45Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/2/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836079
Page 188 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
Mar-11-2021 00:38:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-10-2021 20:45:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered updated form faxed to
safety this afternoon
Mar-09-2021 10:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON: Per
confirmation from PSSR,
no follow-up has been
received downgrading the
events to non serious.
Please submit a follow up
SAE form to indicate that
the events are no longer
serious.
Mar-08-2021 01:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-04-2021 22:44:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered safety form updated from
serious AE to just an AE
Mar-03-2021 09:35:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021113437
Calcified cerebral
meningioma(onset
date:31Jan2021)was
reported as serious in
Safety database but
nonserious in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836080
Page 189 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), th
is event is due to:
OTHER
If Other, specify:
incidental finding not requiring su
rgery after fall from walking dogInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836081
Page 190 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836082
Page 191 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
arachnoid cystInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 15:45Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/2/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836083
Page 192 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
Mar-11-2021 00:38:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-10-2021 20:45:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered updated form faxed to
safety this afternoon
Mar-09-2021 10:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON: Per
confirmation from PSSR,
no follow-up has been
received downgrading the
events to non serious.
Please submit a follow up
SAE form to indicate that
the events are no longer
serious.
Mar-08-2021 01:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Pending SDB update
Mar-04-2021 22:42:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered safety form updated from
serious to just AE
Mar-03-2021 09:36:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021113437
Intracranial arachnoid
cyst(onset
date:31Jan2021)was
reported as serious in
Safety database but
nonserious in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836084
Page 193 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), th
is event is due to:
OTHER
If Other, specify:
incidental finding not requiring su
rgery after fall from walking dogInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836085
Page 194 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836086
Page 195 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
fall from walking dogInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/31/2021 15:45Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/2/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836087
Page 196 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), th
is event is due to:
OTHER
If Other, specify:
fall from walking dogInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836088
Page 197 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-16-2021 22:33:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836089
Page 198 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
soreness at the injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/14/2021 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836090
Page 199 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  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
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836091
Page 200 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-05-2021 16:06:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836092
Page 201 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-26-2020 16:04:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836093
Page 202 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-09-2021 17:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836094
Page 203 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-26-2020 16:04:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-26-2020 16:04:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-26-2020 16:04:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Oct-26-2020 16:04:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Influenza VaccinationInitial Entry
5. Date:
Date Location User Value Reason
Oct-26-2020 16:04:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836095
Page 204 of 231
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-09-2021 17:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
2. Category:
Date Location User Value Reason
Feb-09-2021 17:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-09-2021 17:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Feb-09-2021 17:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Tetanus vaccineInitial Entry
5. Date:
Date Location User Value Reason
Feb-18-2021 16:44:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-16-2021 22:34:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Feb-11-2021 16:33:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
clarify date as this is
<28 days from Vaccine.
If date correct as is,
please mark as a PD.
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836096
Page 205 of 231
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-09-2021 17:48:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836097
Page 206 of 231
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 15:39:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836098
Page 207 of 231
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021 15:39:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible per local/national recommen
dations and confirmed to have receiv
ed only placebo at Vaccination 1/2Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836099
Page 208 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 15:57:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836100
Page 209 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-13-2021 15:57:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/13/2021Initial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836101
Page 210 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-13-2021 15:58:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-13-2021 15:58:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-13-2021 15:58:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff5\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836102
Page 211 of 231
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601035 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-13-2021 15:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-13-2021 15:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-13-2021 15:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-13-2021 15:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-13-2021 15:58:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
N
…[truncated]