125742 S1 M5 CRF c4591001 1260 12601018

Document text

Page 1 of 212
***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: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835681
Page 2 of 212
***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: 12601018 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/28/2020
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835682
Page 3 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12601018]
2.Birth Date: 1994
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835683
Page 4 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835684
Page 5 of 212
***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: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835685
Page 6 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835686
Page 7 of 212
***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: 12601018 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:[seasonal allergies ]
Start Date: //
Ongoing: YES
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835687
Page 8 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [134.6]
3.Unit: LB
4.Height: [69.4]
5.Unit: in
6.Body Mass Index: [19.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835688
Page 9 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [72251]
3.Randomization Group: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835689
Page 10 of 212
***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: 12601018 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/28/2020
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 [BPT75S]
5.bSample ID [BPT75T]
5.cSample ID [BPT75V]
5.dSample ID [BNV64L]
5.eSample ID [BNV64M]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835690
Page 11 of 212
***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: 12601018 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/28/2020
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 [BPT75R]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835691
Page 12 of 212
***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: 12601018 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/28/2020 13:52
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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835692
Page 13 of 212
***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: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835693
Page 14 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835694
Page 15 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835695
Page 16 of 212
***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: 12601018 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/17/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP26MV]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835696
Page 17 of 212
***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: 12601018 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/17/2020 13:10
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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835697
Page 18 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835698
Page 19 of 212
***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: 12601018 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/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP26TC]
5.bSample ID [BNV6F8]
5.cSample ID [BNV6F9]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835699
Page 20 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835700
Page 21 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/9/2020
2.Date of First Symptom Started: Oct/6/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835701
Page 22 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Symptoms - Other
5.aSymptoms - Other Text: [runny nose]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835702
Page 23 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Insta
nce
 1. DELETED Oct/8/20
20 SWABBED
MATERIAL
 THROAT  SEVERE ACUTE RESP SY
NDROME CORONAVIRU
S 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835703
Page 24 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/8/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: THROAT
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [UMass Molecular Virology Laboratory 2019-nCoV rRT- ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835704
Page 25 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 12601018 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_SELF
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV18752]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835705
Page 26 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: 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: 12601018 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[self swab done]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835706
Page 27 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835707
Page 28 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835708
Page 29 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835709
Page 30 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835710
Page 31 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835711
Page 32 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835712
Page 33 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835713
Page 34 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835714
Page 35 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835715
Page 36 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835716
Page 37 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835717
Page 38 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835718
Page 39 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835719
Page 40 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835720
Page 41 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835721
Page 42 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835722
Page 43 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835723
Page 44 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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.Start Date: //
6.Ongoing?
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835724
Page 45 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835725
Page 46 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835726
Page 47 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/19/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835727
Page 48 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/19/2020Form: 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: 12601018 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:
Nov/19/2020
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 [BP26YV]
5.bSample ID [BNTX9Y]
5.cSample ID [BNTX9Z]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835728
Page 49 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835729
Page 50 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835730
Page 51 of 212
***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: 12601018 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/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835731
Page 52 of 212
***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: 12601018 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: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835732
Page 53 of 212
***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: 12601018 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:
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835733
Page 54 of 212
***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: 12601018 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 [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835734
Page 55 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  soreness at the injection si
te Jan/1/2021 08
:00 NO
End Date Time:
Jan/1/2021 12:00
 Repeating
Pages
 2.ADVERSE EV
ENT 2  headache  Jan/1/2021 08
:00 NO
End Date Time:
Jan/1/2021 12:00
 Repeating
Pages
 3.ADVERSE EV
ENT 3  lymph node swelling in le
ft armpit Jan/22/2021 1
8:00 NO
End Date Time:
Jan/23/2021 07:00
 Repeating
Pages
 4.ADVERSE EV
ENT 4  fatigue  Jan/23/2021 0
7:00 NO
End Date Time:
Jan/23/2021 12:00
 Repeating
Pages
 5.ADVERSE EV
ENT 5  malaise  Jan/23/2021 0
7:00 NO
End Date Time:
Jan/23/2021 12:00
 Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835735
Page 56 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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)[soreness at the injection site]
4.Start Date Time: Jan/1/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/1/2021 12:00
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?YES
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835736
Page 57 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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[ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835737
Page 58 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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)[headache]
4.Start Date Time: Jan/1/2021 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/1/2021 12:00
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?YES
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835738
Page 59 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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[ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835739
Page 60 of 212
***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: 12601018 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)[lymph node swelling in left armpit]
4.Start Date Time: Jan/22/2021 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/23/2021 07:00
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?YES
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835740
Page 61 of 212
***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: 12601018 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[ ]
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(b) (4)
FDA-CBER-2021-5683-0835741
Page 62 of 212
***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: 12601018 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)[fatigue]
4.Start Date Time: Jan/23/2021 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/23/2021 12:00
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?YES
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835742
Page 63 of 212
***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: 12601018 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[ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835743
Page 64 of 212
***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: 12601018 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)[malaise]
4.Start Date Time: Jan/23/2021 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/23/2021 12:00
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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835744
Page 65 of 212
***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: 12601018 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[ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835745
Page 66 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835746
Page 67 of 212
***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: 12601018 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[ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835747
Page 68 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.1  VACCINATIONS  NO  influenza vaccin
ation Oct/1/20
20 Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835748
Page 69 of 212
***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: 12601018 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/1/2020
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(b) (4)
FDA-CBER-2021-5683-0835749
Page 70 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835750
Page 71 of 212
***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: 12601018 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?
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835751
Page 72 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835752
Page 73 of 212
***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: 12601018 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?
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835753
Page 74 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835754
Page 75 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835755
Page 76 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835756
Page 77 of 212
***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: 12601018 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:
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835757
Page 78 of 212
***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: 12601018 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?
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835758
Page 79 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835759
Page 80 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835760
Page 81 of 212
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835761
Page 82 of 212
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835762
Page 83 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/31/2020
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835763
Page 84 of 212
***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: 12601018 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
Dec/31/2020
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835764
Page 85 of 212
***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: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835765
Page 86 of 212
***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: 12601018 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 :Dec/31/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835766
Page 87 of 212
***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: 12601018 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:
Dec/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 [BPVNTM]
5.bSample ID [BNTXCR]
5.cSample ID [BNTXCS]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835767
Page 88 of 212
***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: 12601018 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:
Dec/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 [BPVNTK]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835768
Page 89 of 212
***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: 12601018 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: Dec/31/2020 10:14
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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835769
Page 90 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/31/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835770
Page 91 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835771
Page 92 of 212
***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: 12601018 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: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835772
Page 93 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835773
Page 94 of 212
***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: 12601018 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/22/2021
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 [BPVNX4]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835774
Page 95 of 212
***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: 12601018 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/22/2021 16:02
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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835775
Page 96 of 212
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835776
Page 97 of 212
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/26/2021
3.Comments: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835777
Page 98 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835778
Page 99 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835779
Page 100 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835780
Page 101 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835781
Page 102 of 212
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Feb/26/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835782
Page 103 of 212
***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: 12601018 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/16/2020
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835783
Page 104 of 212
***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: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835784
Page 105 of 212
***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: 12601018 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
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835785
Page 106 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-29-2020 10:33:10 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0835786
Page 107 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormDec-31-2020 11:03:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835787
Page 108 of 212
***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: 12601018 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 Jan-26-2021 20:52:41 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Jan-25-2021 15:40:50 (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 Nov-23-2020 14:05:22 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-26-2020 13:54:18 (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.
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835788
Page 109 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
 N/A Oct-22-2020 09:22:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Oct-20-2020 21:06:13 (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 Oct-20-2020 13:50:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Oct-16-2020 12:41:01 (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.
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835789
Page 110 of 212
***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: 12601018 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-29-2020 10:32:28
(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-29-2020 10:32:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835790
Page 111 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-29-2020 10:42:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-29-2020 10:42:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Transcription Error
Aug-29-2020 10:33:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Aug-29-2020 10:32:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Apr/28/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835791
Page 112 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-29-2020 10:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12601018Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-29-2020 10:30:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1994Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-29-2020 10:32:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-29-2020 10:32:53
(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-29-2020 10:32:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ff2\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-2021-5683-0835792
Page 113 of 212
***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: 12601018 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-29-2020 10:33:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835793
Page 114 of 212
***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: 12601018 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-29-2020 10:33:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-29-2020 10:33:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-29-2020 10:33:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835794
Page 115 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 22:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:1
Medical History
Term:seasonal alle
rgies
Start Date:
Ongoing: YESTranscription Error
(DELETED)
Aug-29-2020 10:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:seasonal alle
rgies
Start Date:
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 22:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Transcription Error
(DELETED)
Aug-29-2020 10:45:09
(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
Sep-01-2020 22:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesTranscription Error
(DELETED)
Aug-29-2020 10:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
090177e196ae3ff2\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-2021-5683-0835795
Page 116 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 22:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
(DELETED)
1.a Ongoing:
Date Location User Value Reason
Sep-01-2020 22:08:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
(DELETED)
Aug-29-2020 10:45:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\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-2021-5683-0835796
Page 117 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
134.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-29-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-29-2020 10:43:36
(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-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-29-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-29-2020 10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Height 69.4 is
outside of Normal
Range 140 - 198 for
090177e196ae3ff2\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-2021-5683-0835797
Page 118 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
cm or 55 - 80 for in.
Aug-29-2020 10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.4Transcription Error
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
176.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-29-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inTranscription Error
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-29-2020 10:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19.6Transcription Error
Aug-29-2020 10:43:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.4
Temperature Unit
:CInitial Entry
090177e196ae3ff2\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-2021-5683-0835798
Page 119 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Temperature Loca
tion::ORAL CAV
ITY
7.a Record Identifier:
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-29-2020 10:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff2\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-2021-5683-0835799
Page 120 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-29-2020 10:44:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-29-2020 10:44:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
72251Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835800
Page 121 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 10:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 10:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 13:49:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 03:07:01
(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-29-2020 10:33:43
(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-29-2020 10:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835801
Page 122 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-31-2020 13:49:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT75SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 13:49:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT75SInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 13:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT75TInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-31-2020 13:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT75TInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 13:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT75VInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-31-2020 13:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT75VInitial Entry
5.d
090177e196ae3ff2\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-2021-5683-0835802
Page 123 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-31-2020 13:50:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV64LInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-31-2020 13:50:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNV64LInitial Entry
5.e
Date Location User Value Reason
Aug-31-2020 13:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV64MInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-31-2020 13:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNV64MInitial Entry
090177e196ae3ff2\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-2021-5683-0835803
Page 124 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-29-2020 10:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-29-2020 10:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 13:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 03:07:12
(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-29-2020 10:33:33
(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-29-2020 10:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835804
Page 125 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Aug-31-2020 13:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT75RInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 13:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT75RInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0835805
Page 126 of 212
***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: 12601018 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-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 13:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3ff2\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-2021-5683-0835806
Page 127 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Aug-29-2020 10:44:42
(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-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-29-2020 10:44:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835807
Page 128 of 212
***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: 12601018 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
Sep-07-2020 06:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-02-2020 12:35:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered it was entered
incorrectly in trialmax
and we have DCFs
trying to correct the
error
Sep-02-2020 06:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'No' however VAX 1
eDiary records are
available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-29-2020 10:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3ff2\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-2021-5683-0835808
Page 129 of 212
***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: 12601018 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-17-2020 13:34:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835809
Page 130 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 13:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 13:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 13:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 13:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 13:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3ff2\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-2021-5683-0835810
Page 131 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-17-2020 13:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835811
Page 132 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 13:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 13:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 14:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 13:34:49
(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-17-2020 13:34:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 14:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26MVInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835812
Page 133 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 14:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP26MVInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835813
Page 134 of 212
***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: 12601018 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-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020 13:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3ff2\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-2021-5683-0835814
Page 135 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Sep-17-2020 13:35:15
(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-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-17-2020 13:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835815
Page 136 of 212
***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: 12601018 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-16-2020 09:41:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835816
Page 137 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 09:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 09:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:50:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-17-2020 09:01:10
(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.
Oct-16-2020 09:41:23
(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-16-2020 09:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835817
Page 138 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-20-2020 13:50:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26TCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:50:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP26TCInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:51:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV6F8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 13:51:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNV6F8Initial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:52:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV6F9Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 13:52:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNV6F9Initial Entry
090177e196ae3ff2\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-2021-5683-0835818
Page 139 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 12601018 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-09-2020 18:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-09-2020 18:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-09-2020 18:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Oct-09-2020 18:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-09-2020 18:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835819
Page 140 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-09-2020 18:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there is
no Other Symptom
reported. Please
review and update
as appropriate.
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved
:
Oct/7/2020Initial Entry
4.a
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Symptoms: FEVERInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835820
Page 141 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) Symptom Present: NO
4.a Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835821
Page 142 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\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-2021-5683-0835822
Page 143 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.e
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae3ff2\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-2021-5683-0835823
Page 144 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.f Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ff2\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) (6)
(b) (4)
FDA-CBER-2021-5683-0835824
Page 145 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) Symptoms: DIARRHEA
Symptom Present: NO
4.h Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-09-2020 18:43:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835825
Page 146 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-09-2020 18:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: runny noseInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-09-2020 18:43:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
runny noseInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835826
Page 147 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-23-2020 17:02:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835827
Page 148 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
THROATInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-09-2020 18:44:39 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835828
Page 149 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00) Eastern
Time (US & Canada)OTHER
7. Test Result:
Date Location User Value Reason
Oct-09-2020 18:44:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-22-2020
17:14:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: C
losedResponse
satisfies query
Oct-22-2020
09:22:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Oct-22-2020
09:22:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
UMass Mo
lecular Vir
ology Lab
oratory 20
19-nCoV r
RT-Transcription
Error
Oct-22-2020
06:33:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1: R
eissued:Op
enedDM: Thank
you for your
response,
Please update
"UMass
Molecular
Virology
Laboratory
090177e196ae3ff2\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-2021-5683-0835829
Page 150 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
2019-nCoV
rRT-PCR Dx
Panel" as
manufacturer
and test kit
name needs to
be recorded.
Oct-20-2020
12:47:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answeredit is on the list
as of 10/1
Oct-20-2020
10:32:35
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
Openedumass
memorial
medical center
is not indicated
on the
FDA-cleared
(including
Emergency Use
Authorization)
diagnostic list
and is not
indicated as
'CLIA-certified
lab' or 'ISO
15189
accredited lab' .
Please verify
and update as
appropriate.
Otherwise,
please provide
clarification.
Oct-09-2020
18:44:39
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000  Data Entr
y:
umass me
morial me
dical centeInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835830
Page 151 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Canada) r
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0835831
Page 152 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 18:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 18:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 19:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 18:44:48
(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-09-2020 18:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/9/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020 19:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV18752Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835832
Page 153 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Oct-09-2020 19:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV18752Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835833
Page 154 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - 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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 18:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 18:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 18:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-09-2020 18:44:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
self swab doneInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835834
Page 155 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae3ff2\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-2021-5683-0835835
Page 156 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contacts
:
1Initial Entry
090177e196ae3ff2\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-2021-5683-0835836
Page 157 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.d
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
090177e196ae3ff2\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-2021-5683-0835837
Page 158 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
090177e196ae3ff2\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-2021-5683-0835838
Page 159 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-09-2020 18:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\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-2021-5683-0835839
Page 160 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-09-2020 18:45:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-09-2020 18:45:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-16-2020 11:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-16-2020 10:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered in florence
Oct-16-2020 10:33:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Please provide
source.
Oct-13-2020 09:27:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-13-2020 09:22:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-13-2020 09:22:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Transcription Error
Oct-12-2020 07:39:22
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Opened DM: Per CRF CRs
Section 8.33.5,
090177e196ae3ff2\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-2021-5683-0835840
Page 161 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/09/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada) please enter worst
toxicity grade (1 to
5) as it relates to
reported symptom(s)
on SOD CRF. Please
review and update
as appropriate.
Oct-09-2020 18:45:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
0Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835841
Page 162 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/19/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020 14:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-23-2020 14:05:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835842
Page 163 of 212
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/19/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020 14:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020 14:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 14:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-23-2020 14:05:30
(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.
Nov-23-2020 14:05:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-23-2020 14:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26YVInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835843
Page 164 of 212
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/19/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 14:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP26YVInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 14:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX9YInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-23-2020 14:16:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX9YInitial Entry
5.c
Date Location User Value Reason
Nov-23-2020 14:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX9ZInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-23-2020 14:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX9ZInitial Entry
090177e196ae3ff2\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-2021-5683-0835844
Page 165 of 212
***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: 12601018 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-16-2020 12:24:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 12:24:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 12:24:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835845
Page 166 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835846
Page 167 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835847
Page 168 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835848
Page 169 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Feb-26-2021 22:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835849
Page 170 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Mar-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835850
Page 171 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-26-2021 20:52:41
(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
Jan-26-2021 20:52:41
(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
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/1/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/1/2021 12:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff2\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-2021-5683-0835851
Page 172 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-26-2021 20:52:41
(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
Jan-26-2021 20:52:41
(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
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-26-2021 20:52:41
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\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) (6)
(b) (4)
FDA-CBER-2021-5683-0835852
Page 173 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-26-2021 20:52:41
(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
Jan-26-2021 20:52:41
(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
Jan-26-2021 20:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835853
Page 174 of 212
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-26-2021 20:54:12
(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
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/1/2021 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/1/2021 12:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff2\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-2021-5683-0835854
Page 175 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-26-2021 20:54:12
(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
Jan-26-2021 20:54:12
(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
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-26-2021 20:54:12
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\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) (6)
(b) (4)
FDA-CBER-2021-5683-0835855
Page 176 of 212
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-26-2021 20:54:12
(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
Jan-26-2021 20:54:12
(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
Jan-26-2021 20:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835856
Page 177 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 22:01:36
(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-26-2021 22:01:36
(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-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lymph node swelling in left armpi
tInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/23/2021 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff2\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-2021-5683-0835857
Page 178 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-26-2021 22:01:36
(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-26-2021 22:01:36
(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-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 22:01:36
(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-26-2021 22:01:36
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\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) (6)
(b) (4)
FDA-CBER-2021-5683-0835858
Page 179 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-26-2021 22:01:36
(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-26-2021 22:01:36
(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-26-2021 22:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835859
Page 180 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Feb-26-2021 22:03:00
(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-26-2021 22:03:00
(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
Mar-02-2021
11:55:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has been
closed.
Mar-02-2021
10:04:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription Error
Mar-02-2021
10:04:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
fatigueTranscription Error
Feb-26-2021
23:19:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedMultiple concepts in
the term
FATIGUE/MALAISE.
Please split the term
into FATIGUE and
MALAISE and
submit separately.
Thank you.
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0835860
Page 181 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-26-2021
22:03:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
fatigue/mal
aiseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-26-2021 22:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/23/2021 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-26-2021 22:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/23/2021 12:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-26-2021 22:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-26-2021 22:03:00
(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.
090177e196ae3ff2\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-2021-5683-0835861
Page 182 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Feb-26-2021 22:03:00
(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-26-2021 22:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-26-2021 22:03:00
(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-26-2021 22:03:00
(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-26-2021 22:03:00
(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-26-2021 22:03:00
(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
090177e196ae3ff2\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-2021-5683-0835862
Page 183 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-26-2021 22:03:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835863
Page 184 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Mar-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-02-2021 10:06:03
(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
Mar-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
malaiseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/23/2021 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/23/2021 12:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff2\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-2021-5683-0835864
Page 185 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-02-2021 10:06:03
(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-02-2021 10:06:03
(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-02-2021 10:06:03
(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-02-2021 10:06:03
(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-02-2021 10:06:03
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\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) (6)
(b) (4)
FDA-CBER-2021-5683-0835865
Page 186 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-02-2021 10:06:03
(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
Mar-02-2021 10:06:03
(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-02-2021 10:06:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835866
Page 187 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-13-2020 12:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835867
Page 188 of 212
***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: 12601018 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-13-2020 12:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-13-2020 12:02:15
(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-13-2020 12:02:15
(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-13-2020 12:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
influenza vaccinationInitial Entry
5. Date:
Date Location User Value Reason
Oct-13-2020 12:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835868
Page 189 of 212
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-31-2020 10:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/31/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835869
Page 190 of 212
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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
Dec-31-2020 10:15:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Transcription Error
Dec-31-2020 10:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835870
Page 191 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-31-2020 10:16:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/31/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835871
Page 192 of 212
***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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-31-2020 10:16:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/31/2020Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835872
Page 193 of 212
***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: 12601018 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
Dec-31-2020 10:16:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-31-2020 10:16:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-31-2020 10:16:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835873
Page 194 of 212
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-31-2020 10:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-31-2020 10:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-31-2020 16:09:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-31-2020 10:18:01
(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.
Dec-31-2020 10:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/31/2020Initial Entry
5.a
Date Location User Value Reason
Dec-31-2020 16:09:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVNTMInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835874
Page 195 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Dec-31-2020 16:09:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPVNTMInitial Entry
5.b
Date Location User Value Reason
Dec-31-2020 16:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTXCRInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-31-2020 16:09:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTXCRInitial Entry
5.c
Date Location User Value Reason
Dec-31-2020 16:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTXCSInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-31-2020 16:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTXCSInitial Entry
090177e196ae3ff2\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-2021-5683-0835875
Page 196 of 212
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-31-2020 10:18:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-31-2020 10:18:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-31-2020 16:09:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-31-2020 10:18:26
(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.
Dec-31-2020 10:18:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/31/2020Initial Entry
5.a
Date Location User Value Reason
Dec-31-2020 16:09:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVNTKInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835876
Page 197 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Dec-31-2020 16:09:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPVNTKInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835877
Page 198 of 212
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/31/2020 10:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3ff2\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-2021-5683-0835878
Page 199 of 212
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-31-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835879
Page 200 of 212
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-26-2021
03:52:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Feb-25-2021
07:51:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-25-2021
07:51:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Dec/3
1/202
0Transcription Error
Feb-25-2021
03:45:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dDM : Form is
unfrozen. Please
review and update data
per previous query.
Thank you.
Feb-24-2021
11:16:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dplease unfreeze query
Feb-23-2021
19:45:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7353520;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
090177e196ae3ff2\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) (4)
FDA-CBER-2021-5683-0835880
Page 201 of 212
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Dec-31-2020
10:14:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Dec/3
0/202
0Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-31-2020 10:14:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835881
Page 202 of 212
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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-25-2021 18:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-25-2021 14:10:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-25-2021 10:58:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete
‘Vaccination form'
at this visit. Thank
you.
Jan-22-2021 15:32:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3ff2\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-2021-5683-0835882
Page 203 of 212
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021 15:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021 15:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 19:07:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-22-2021 15:32:31
(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.
Jan-22-2021 15:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021 19:07:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPVNX4Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835883
Page 204 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.a Sample ID
Date Location User Value Reason
Jan-22-2021 19:07:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPVNX4Initial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835884
Page 205 of 212
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 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
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021 16:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3ff2\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-2021-5683-0835885
Page 206 of 212
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
7. Route:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-25-2021 14:10:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff2\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0835886
Page 207 of 212
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 12601018 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 21:56:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
090177e196ae3ff2\Final\Fin
…[truncated]